Stiffness Assessment and Lump Detection in Minimally Invasive Surgery Using In-House Developed Smart Laparoscopic Forceps.

Minimally invasive surgery (MIS) incorporates surgical instruments through small incisions to perform procedures. Despite the potential advantages of MIS, the lack of tactile sensation and haptic feedback due to the indirect contact between the surgeon's hands and the tissues restricts sensing the strength of applied forces or obtaining information about the biomechanical properties of tissues under operation. Accordingly, there is a crucial need for intelligent systems to provide an artificial tactile sensation to MIS surgeons and trainees. This study evaluates the potential of our proposed real-time grasping forces and deformation angles feedback to assist surgeons in detecting tissues' stiffness. A prototype was developed using a standard laparoscopic grasper integrated with a force-sensitive resistor on one grasping jaw and a tunneling magneto-resistor on the handle's joint to measure the grasping force and the jaws' opening angle, respectively. The sensors' data are analyzed using a microcontroller, and the output is displayed on a small screen and saved to a log file. This integrated system was evaluated by running multiple grasp-release tests using both elastomeric and biological tissue samples, in which the average force-to-angle-change ratio precisely resembled the stiffness of grasped samples. Another feature is the detection of hidden lumps by palpation, looking for sudden variations in the measured stiffness. In experiments, the real-time grasping feedback helped enhance the surgeons' sorting accuracy of testing models based on their stiffness. The developed tool demonstrated a great potential for low-cost tactile sensing in MIS procedures, with room for future improvements. Significance: The proposed method can contribute to MIS by assessing stiffness, detecting hidden lumps, preventing excessive forces during operation, and reducing the learning curve for trainees.

Ovarian cyst elevation using a metreurynter for laparoscopic cystectomy of a benign ovarian cyst during pregnancy.

BACKGROUND: A uterine manipulator cannot be used to elevate the ovary in benign ovarian surgery during pregnancy. This report describes our method of elevation of the ovary using a metreurynter with the success rate of the procedure and a comparison of surgical results and pregnancy outcomes between the successful and unsuccessful cases. METHODS: Between August 2003 and February 2020, 11 pregnant patients with a tumor found sunk in the Cul-de-sac underwent laparoscopic cystectomy for a benign ovarian cyst with a metreurynter. The surgical results, success and failure of the elevation by a metreurynter, pregnancy outcomes, and fetal status at delivery were evaluated. RESULTS: Elevation of ovarian tumors with a metreurynter was successful in nine cases. However, it was unsuccessful in the remaining two cases wherein the ovary was lifted with forceps while the uterus was in a compressed state. The operative time was also longer in these cases. The pregnancy prognosis, however, was good for both, successful and unsuccessful cases. CONCLUSIONS: The metreurynter is an inexpensive and practical obstetric device, and its optimal use allows the performance of a procedure with minimal burden on a pregnant uterus. Therefore, we recommend the appropriate use of this method to enable effective laparoscopic cystectomy of ovarian tumors during pregnancy.

Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Electrosurgical Clip Cutting System. Final order.

The Food and Drug Administration (FDA or we) is classifying the endoscopic electrosurgical clip cutting system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the endoscopic electrosurgical clip cutting system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; General and Plastic Surgery Devices; Classification of the Irrigating Wound Retractor Device. Final order.

The Food and Drug Administration (FDA or we) is classifying the irrigating wound retractor device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the irrigating wound retractor device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Gastroenterology-Urology Devices; Manual Gastroenterology-Urology Surgical Instruments and Accessories. Final rule; technical amendment.

The Food and Drug Administration (FDA) is amending the identification of manual gastroenterology-urology surgical instruments and accessories to reflect that the device does not include specialized surgical instrumentation for use with urogyencologic surgical mesh specifically intended for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures ("specialized surgical instrumentation for use with urogynecologic surgical mesh"). These amendments are being made to reflect changes made in the recently issued final reclassification order for specialized surgical instrumentation for use with urogynecologic surgical mesh.

Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh. Final order.

The Food and Drug Administration (FDA or the Agency) is reclassifying surgical instrumentation for use with urogynecologic surgical mesh from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and identifying them as "specialized surgical instrumentation for use with urogynecologic surgical mesh." FDA is designating special controls that are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is reclassifying this device on its own initiative based on new information.

Medical Devices; Cardiovascular Devices; Classification of the Apical Closure Device. Final order.

The Food and Drug Administration (FDA) is classifying the apical closure device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the apical closure device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Medical Devices; General and Plastic Surgery Devices; Classification of the Magnetic Surgical Instrument System. Final order.

The Food and Drug Administration (FDA) is classifying the Magnetic Surgical Instrument System into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the magnetic surgical instrument system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Management of surgical instruments with radio frequency identification tags.

PURPOSE: To prevent malpractices, medical staff has adopted inventory time-outs and/or checklists. Accurate inventory and maintenance of surgical instruments decreases the risk of operating room miscounting and malfunction. In our previous study, an individual management of surgical instruments was accomplished using Radio Frequency Identification (RFID) tags. The purpose of this paper is to evaluate a new management method of RFID-tagged instruments. DESIGN/METHODOLOGY/APPROACH: The management system of RFID-tagged surgical instruments was used for 27 months in clinical areas. In total, 13 study participants assembled surgical trays in the central sterile supply department. FINDINGS: While using the management system, trays were assembled 94 times. During this period, no assembly errors occurred. An instrument malfunction had occurred after the 19th, 56th, and 73 th uses, no malfunction caused by the RFID tags, and usage history had been recorded. Additionally, the time it took to assemble surgical trays was recorded, and the long-term usability of the management system was evaluated. ORIGINALITY/VALUE: The system could record the number of uses and the defective history of each surgical instrument. In addition, the history of the frequency of instruments being transferred from one tray to another was recorded. The results suggest that our system can be used to manage instruments safely. Additionally, the management system was acquired of the learning effect and the usability on daily maintenance. This finding suggests that the management system examined here ensures surgical instrument and tray assembly quality.

Instruments in rhinoplasty: who is behind the name?

Rhinoplasty is considered one of the most commonly performed and most challenging operations in facial plastic surgery. The modern facial plastic surgeon utilizes many instruments in performing this procedure. Many of these instruments take their names from the pioneers who invented or designed them. Although meritorious, the recent trend in medicine to move away from eponyms in lieu of descriptive names should not come at the price of forgetting history. Although this communication does not seek to provide a comprehensive history of rhinoplasty or of its pioneers, our aim is to mention several of the salient contributing figures upon whose shoulders we stand and whose eponymous instruments we use commonly in rhinoplasty.

Medical devices; gastroenterology-urology devices; classification of the implantable transprostatic tissue retractor system. Final order.

The Food and Drug Administration (FDA) is classifying the implantable transprostatic tissue retractor system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Occult risk of broken instruments for endoscopy-assisted surgery.

BACKGROUND: The influence of broken sophisticated surgical instruments on the safety of surgery has yet to be determined, in spite of an assumption that breakage of surgical instruments is not associated with critical incidents. The purpose of the present study was to delineate the risk from breakage of surgical instruments used in surgery assisted by endoscopy. METHODS: A retrospective analysis was conducted to determine the frequency of breakage of instruments used in 39,817 operations from 2007 to 2011. Data of breakage were collected using incident/near-incident reports and the request forms for repair of broken instruments. RESULTS: During the study period, 441 instruments were reported to be broken intraoperatively, and 7,541 were found to be broken on inspection. The incidence of breakage adjusted by the number of operations and the number of uses suggested that instruments for endoscopy-assisted surgery are broken more frequently intraoperatively than are any other type of instruments (visceral surgery: 0.039 versus 0.017, P = 0.0002, RR = 2.318; obstetrics/gynecology: 0.023 versus 0.0067, P < 0.0001, RR = 3.461; thoracic surgery: 0.019 versus 0.004, P = 0.0772, RR = 5.212). Inappropriate use and wearing out were two major possible causes of breakage of instruments. The predominant adverse events were suggested to be attributable to parts falling off broken instruments because of inappropriate use. CONCLUSIONS: Our results demonstrated that surgery assisted by endoscopy has its own occult risk, which has not been previously highlighted. Minimally invasive surgery is not necessarily safe with respect to breakage of surgical instruments. Our data provide substantial evidence for higher risk of instrument breakage in endoscopy-assisted surgery, as well as its possible detrimental effect on patient safety.

Medical devices; general and plastic surgery devices; classification of the powered surgical instrument for improvement in the appearance of cellulite. Final order.

The Food and Drug Administration (FDA) is classifying the powered surgical instrument for improvement in the appearance of cellulite into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Medical devices; general and plastic surgery devices; classification of the absorbable lung biopsy plug. Final order.

The Food and Drug Administration (FDA) is classifying the absorbable lung biopsy plug into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the absorbable lung biopsy plug's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Medical devices; ophthalmic devices; classification of the scleral plug. Final rule.

The Food and Drug Administration (FDA or Agency) is classifying the scleral plug into class II (special controls), and exempting the scleral plugs composed of surgical grade stainless steel (with or without coating in gold, silver, or titanium) from premarket notification (510(k)) and continuing to require premarket notification (510(k)) for all other scleral plugs in order to provide a reasonable assurance of safety and effectiveness of the device. The scleral plug is a prescription device used to provide temporary closure of a scleral incision during an ophthalmic surgical procedure.