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.

Medical Devices; Obstetrical and Gynecological Devices; Classification of the Gynecologic Laparoscopic Power Morcellation Containment System. Final order.

The Food and Drug Administration (FDA) is classifying the gynecologic laparoscopic power morcellation containment 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 gynecologic laparoscopic power morcellation containment 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.

Mini-laparoscopic live donor nephrectomy with the use of 3-mm instruments and laparoscope.

PURPOSE: To analyze our preliminary outcomes on the use of 3 mm instruments for laparoscopic live donor nephrectomy (LLDN). METHODS: Our series includes thirteen patients, who underwent LLDN using 3-mm instruments and laparoscope and 5-mm transumbilical trocar. The patients were followed at 7 and 14 days from discharge and were specifically asked about their cosmetic satisfaction. At follow-up, the recipient graft function was controlled, as well as the donor's cosmetic results. Eight months after surgery, all thirteen patients were asked to fill out the Patient Scar Assessment Questionnaire and Scoring System (PSAQ). RESULTS: All patients presented good recovery after surgery. Regarding cosmetic outcomes, the donors expressed their satisfaction toward the minimal incision size and optimal esthetic results at 7 and 14 days from discharge home. The low scores on each section of the PSAQ confirmed the favorable outcomes. Early graft function was satisfactory at 1 and 3 months after the kidney transplantation. Furthermore, there were no major complications in the recipients. CONCLUSIONS: Our persistent positive results with the use of 3-mm instruments during LLDN support this technique as a good alternative to the standard laparoscopic approach for minimizing the incision site, while maintaining safety and excellent clinical outcomes. The fact that the general laparoscopic standards are maintained could make this approach a very attractive alternative to the other minimally invasive approaches for live donor nephrectomy. The hope is in that the higher degree of satisfaction in the donor population demonstrated in this study may likely enhance living kidney donation.

A review of laparoscopic ureteral injury in pelvic surgery.

The objective of this study was to review the body of literature in reference to ureteral injury during laparoscopic surgeries and to determine: 1) the reported rates of ureteral injury; 2) the initial laparoscopic surgeries during which ureteral injury occurred; 3) the time of injury recognition (intra- versus postoperative); 4) the type, 5) the location, and 6) the mode of injury repair; and 7) the surgical laparoscopic instruments involved in ureteral injury. The appropriate medical subject heading (MSH) terms were selected and used in a search of the Medline computerized database and the online American College of Obstetricians and Gynecologists database. World literature published in the English language on ureteral injury during laparoscopic surgery between 1966 and 2003 was reviewed.A total of 70 reported instances of ureteral injury during laparoscopic surgery were identified among 2491 reported cases in which ureteral laparoscopic complications were discussed. Incidences of injury ranged from <1% to 2%. These 2491 cases of laparoscopy were presented as a mixed group, which included case reports, small series of studies, as well as longer, consecutive studies. In 18 of the 70 (25.7%) cases, the initial laparoscopic procedures during which ureteral injury occurred were not described or specified. In cases in which the type of laparoscopic surgery was specified, 14 of the 70 (20.0%) total cases of ureteral injury occurred during laparoscopically assisted vaginal hysterectomy (LAVH). Ureteral injury was identified intraoperatively in 6 of 70 (8.6%) cases, postoperatively in 49 of 70 (70.0%) cases, and, in 15 of 70 (21.4%) cases, the time of diagnosis was not specified. In 36 of the 70 (51.4%) reported injuries, the type of injury was not specified or described. In instances in which the types of injury were described, transection occurred most commonly, accounting for 14 of 70 (20.0%) injuries. The location of ureteral injury was not specified in 46 of the 70 (65.7%) cases. When location was specified, injuries most often occurred at or above the pelvic brim, accounting for 10 of the total 70 (14.3%). Electrocautery was involved in 17 of the 70 (24.3%) cases of ureteral injury, but in 34 of the 70 (48.6%) cases, the surgical laparoscopic instrument involved was not reported. A laparotomy was used to repair the ureteral injury in 43 of 70 (61.4%) cases.Ureteral injuries reported in peer-reviewed journals often lack detailed presentation of the initial laparoscopic surgeries during which ureteral injury occurred, or of the type, the location, and the instrumentation involved in ureteral injury. A high incidence of ureteral injury was found among the laparoscopic procedures analyzed in this review. Laparoscopically-assisted vaginal hysterectomy was the leading procedure in which injury occurred, and instruments involved in electrocoagulation were associated with the most injuries incurred during laparoscopic surgery.