Adverse Events Related to Laser Fibers and Laser Machines During Ureteroscopy and Stone Lithotripsy : Insights from an Updated 10-Year Analysis of the US MAUDE Database

INTRODUCTION Ureteroscopy has become increasingly chosen as a treatment of choice for patients with kidney stone disease and laser as the energy source for stone lithotripsy is a key part of this. Our aim was to analyse a national database to evaluate the burden of adverse events related to laser fibers and laser machines. METHODS Search was performed of the Manufacturer User and Facility Device Experience (MAUDE) database in the United States for all events related to holmium laser fibers and holmium laser machines during ureteroscopy between 2012-2021. Information collected included the following: problem, timing, prolonged anaesthesia, early termination of procedure, injury and retained parts. RESULTS 699 holmium laser fiber events were reported and these had been manufactured by 13 different companies. The commonest problems were breakage outside the patient while in use (26.3%) and breakage of the laser fiber tip (21.2%). Manufacturers concluded root cause to be device failure in 8.9%. 29% of issues occurred before the laser had been activated. 5.2% of cases had to be cancelled as a result of an event. Significantly more injuries were sustained intra-operatively by operating staff compared to patients (6% vs. 0.2%, p < 0.001). All these injuries were superficial burns to the skin with the hand being the most affected body part (88.1%). Zero ocular injuries were reported. Only eight events were related to laser machines and all involved sudden hardware failure but no patient injury. CONCLUSIONS Laser fibers are fragile. Most adverse events are due to operator error. Direct patient injury from laser fiber is scarce but operating staff should be aware of the risk of sustaining minor burns. Laser machines rarely incur problems and, in this study, did not result in any safety issues beyond need to abort the procedure due to lack of spare equipment.