ABSTRACT
PURPOSE: The present study was aimed at determining common causes of sialendoscopy device malfunctions and identifying a uniform algorithm to manage device failures. MATERIALS AND METHODS: The FDA Manufacturer and User Facility Device Experience (MAUDE) database was searched for various keywords related to sialendoscopy. Reports between the dates of December 1, 2009 to March 31, 2020 were downloaded for review and included in the study. Variables such as: device, the iatrogenic injury type, and subsequent surgical or medical intervention were collected and details of the malfunction were categorized based on the type of malfunction. RESULTS: 206 medical device reports were identified; 47 of them which met inclusion criteria (106 were duplicate cases and 53 were irrelevant to the present study). The majority of device malfunctions involved salivary stone extractor baskets (SSEBs), (40/47; 85.1%), followed by malfunctions of balloon dilators (3/47; 6.4%) and sialendoscopes (2/47; 4.3%). Retention of the SSEB was noted in 85% of the SSEB malfunctions. CONCLUSIONS: Given that sialendoscopy is an increasingly popular technique that relies on devices, it is inevitable that device failures will occur for a multitude of reasons. Working to prevent these malfunctions from occurring is the most effective method of harm reduction. Though it is important that sialendoscopists have a discrete, algorithmic approach to manage them when they occur.
