PD30-08 DEVICE-RELATED DEVIATION DURING PERCUTANEOUS NEPHROLITHOTOMY: REVIEW OF THE MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE (MAUDE) DATABASE

You have accessJournal of UrologyStone Disease: Surgical Therapy III1 Apr 2017PD30-08 DEVICE-RELATED DEVIATION DURING PERCUTANEOUS NEPHROLITHOTOMY: REVIEW OF THE MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE (MAUDE) DATABASE Neel Patel, Ariel Schulman, Nikil Uppaluri, John Phillips, Muhammad Choudhury, Sensuke Konno, and Majid Eshghi Neel PatelNeel Patel More articles by this author , Ariel SchulmanAriel Schulman More articles by this author , Nikil UppaluriNikil Uppaluri More articles by this author , John PhillipsJohn Phillips More articles by this author , Muhammad ChoudhuryMuhammad Choudhury More articles by this author , Sensuke KonnoSensuke Konno More articles by this author , and Majid EshghiMajid Eshghi More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.1373AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Percutaneous nephrolithotomy (PCNL) is a standard approach for the access to and treatment of large stones from the upper urinary tract. PCNL is a complex, multistep surgery requiring multiple classes of devices. Malfunctions of devices are important to best address issues of patient safety and surgical quality which has not yet been standardized. Herein we describe the first reports of device-related malfunctions during PCNL reported in the Manufacturer and User facility Device Experience (MAUDE) database. METHODS The publicly available MAUDE database was examined for device-related deviation, impediment for use, or frank malfunction during PCNL. The database was queried for ″percutaneous nephrolithotomy″ for reports from 2005 to 2016. Duplicate cases, cases with incomplete data, or non-verifiable reporter cases were excluded. RESULTS A total of 218 reports were identified with the most common reported device classes including the lithotripter 53 (24.3%), wires 43 (19.7%), balloon dilators 30 (13.8%) and occlusion balloons 28 (12.8%). The most common deviation included broken off device fragments with use of wires and lithotripters while a bursting balloon was the most common balloon-reported malfunction. Resultant complications to the patient included need for a second procedure 12 (24.4%), bleeding 8 (16.3%), retained stone fragments 7 (14.2%), prolonged procedure 4 (8.2%), ureteral injury 2 (4.1%) and conversion to an open procedure 2 (4.1%). Reporters included the physician 143 (65.5%), nursing staff 18 (8.3%) and risk manager 10 (4.6%) and the device was evaluated by the manufacturer in 93 (42.7%) of cases. CONCLUSIONS A wide range of device-related deviation from diverse product classes is reported during PCNL that in select cases resulted in patient morbidity. A working knowledge of the scope of potential malfunctions is critical during performance of this multistep procedure. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e580-e581 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Neel Patel More articles by this author Ariel Schulman More articles by this author Nikil Uppaluri More articles by this author John Phillips More articles by this author Muhammad Choudhury More articles by this author Sensuke Konno More articles by this author Majid Eshghi More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...