Adverse events related to accessory devices used during ureteroscopy: Findings from a 10‐year analysis of the Manufacturer and User Facility Device Experience (MAUDE) database

Abstract

AbstractObjectivesThe objective of this study was to evaluate adverse events and device events related to accessories used during ureteroscopy (URS).Materials and methodsAnalysis was performed of the records available in the Manufacturer and User Facility Device Experience database in the United States. Information was collected on characteristics of problem, timing, manufacturer verdict, successful completion of planned surgery, prolonged anaesthesia and injury to patient or staff.ResultsFive‐hundred seventy‐one events related to URS accessories were recorded. These were associated with the following devices: baskets (n = 347), access sheath (n = 86), guidewires (n = 78), balloon dilators (n = 27), ARDs (n = 17) and ureteral catheters (n = 16). Of the events, 12.7% resulted in patient injuries. Forty‐eight per cent of the events resulted in prolonged anaesthesia, but the planned surgery was successfully completed in 78.4% of all cases. Collectively, the manufacturers accepted responsibility due to actual device failure in only 0.5% of cases. Common problems for baskets were failure to deploy (39.5%) and complete detachment of basket head (34.6%) and partial breakage of the basket head (12.4%). Of the basket group, 4.3% required open or percutaneous surgery to remove stuck basket. Full break of the body of the access sheath occurred in 41.9% and complete ureteral avulsion in 3.5%. For balloon dilators, there was a burst in 37% of cases. Broken guidewires were associated with 11.5% requiring repeat intervention for retrieval and 6.4% required JJ stent due to perforation to the collecting system. No injuries to operating staff were recorded with accessory usage.ConclusionAccessories used during URS are fragile. Potential for serious injury does exist as a direct result of their use. Surgeons should familiarise themselves with these events and how they can be prevented.