Adverse event reporting in head and neck transoral robotic surgery: a MAUDE database study.

ABSTRACT

Transoral robotic surgery (TORS) using the da Vinci Surgical system was approved by the US Food and Drug Administration in 2009. Currently, most available safety information on TORS procedures describes adverse events occurring in the context of clinical trials or series at high-volume academic centers. The goal of this study was to catalog reported adverse events associated with the da Vinci device in head and neck procedures by querying an FDA database. A search was performed on the MAUDE database inspecting for TORS safety incident reports generated from January 2009 through May 2020 using key words "da Vinci" and "Intuitive Surgical". A total of 3312 medical device records were produced. Of these 36 head and neck adverse events, reports were identified through manual screening of the data by the authors. Death was found to be the most common adverse event reported overall, manifesting in 44% of all reported incidents. The most frequent source of mortality was found to be hemorrhaging in the perioperative period rather than incidents of device malfunction or structural damage from surgery. This was found to be similar to the results of other published series for transoral ablative surgery. This study suggests that the small number of reported adverse events related to TORS with the da Vinci system seems to mirror what would be expected from the same procedures using other methods for transoral surgery.