Abstract: PD30-08
Sources of Funding: none

Introduction

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. _x000D_

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 &[Prime]percutaneous nephrolithotomy&[Prime] for reports from 2005 to 2016. Duplicate cases, cases with incomplete data, or non-verifiable reporter cases were excluded. _x000D_ _x000D_

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. _x000D_

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. _x000D_

Funding

none