Endometrial ablation devices: review of a manufacturer and user facility device experience database

Our objective was to evaluate complications reported to the Manufacturer and User Facility Device Experience (MAUDE) database and to look for trends of complications among various endometrial ablation devices. This database was not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices. We performed a retrospective review of the Food and Drug Administration's MAUDE database. The database was queried for adverse events associated with the use of endometrial ablation devices. The following data were collected: event number, date reported, date of occurrence, type of ablation device, type of complication, adherence to manufacturer's protocol, brief description, disposition, who reported incident, report source, and cause of problem. The total number of adverse events reported in the United States for the time period January 1, 2003, through December 31, 2006, was 254. The largest number of major complications for cryoablation was bowel injury (n = 5), for microwave was bowel injury (n = 6), for hot water balloon was complications leading to hysterectomy (n = 7), for free circulating hot water was severe burns (n = 22), and for bipolar mesh was bowel injury (n = 19). The MAUDE database is useful to both the physician and manufacturer to look at trends and types of complications.