The manufacturer and User Facility Device Experience (MAUDE) databases is FDA database that contains medical device incidents reports. For this study Dr. Patel and team searched and reviewed the MAUDE database for medical device malfunctions and patient injuries during PCNL procedures in the United States from 2006 to 2016. Each incident report was then separated by device class, type of device, malfunction that occurred, and other potential complications. They were then classified using a novel classification system proposed in a previous study. In this system device complications are divided into four categories from Level I (mild with no harm to the patient) to Level IV (life threatenting/death).
A total of 218 medical device reports were reviewed for this study. Dr. Patel and team highlighted the five most common devices they found in their review (Lithotripter, wire, balloon dilators, occlusion balloons, nephrostomy tubes) and found that the majority (92.6%) were Level I or Level II in the MAUDE classification system. A total of 42 complications were reported with the most common being second procedure needed, bleeding, residual fragments, prolonged procedures, and conversion to open. The most common device malfunctions were seen in Lithotriptors and wires with detachment of the device being the most common issue. Balloon dilator and occlusion balloons were commonly associated with balloon ruptures.
Dr. Patel concluded that this study may provide a new method to standardize complication that occur during a PCNL procedure. He added that even though the majority of PCNL complications were Level I and caused no harm to the patients, serious events occurred in up to 20% of complications mainly due to operator misuse. Lastly, he stated that these finding highlight the importance of training urologists in the proper operation and management of device and that this may help to improve surgical performance and reduce complications.
Presented by: Neel Patel
Authors: Neel H. Patel, Ariel A. Schulman, Jonathan B. Bloom, Nikil Uppaluri, John L. Phillips, Sensuke Konno, Muhammad Choudury, Majid Eshghi
Affiliation: New York Medical College
Written by: Renai Yoon, Department of Urology, University of California-Irvine at the 35th World Congress of Endourology – September 12-16, 2017, Vancouver, Canada