AQUABEAM ROBOTIC SYSTEM

Additional Manufacturer Narrative

COMPONENT CODE = 4756, AQUABEAM MOTORPACK. A REUSABLE COMPONENT OF THE AQUABEAM ROBOTIC SYSTEM. ROOT CAUSE OF THE REPORTED EVENT HAS NOT YET BEEN ESTABLISHED. INVESTIGATION BY MANUFACTURER IS CURRENTLY IN PROCESS. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

Description of Event or Problem

A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT DURING AQUABLATION THERAPY, THE WATERJET STOPPED WORKING, AND THERE WAS NO CONNECTION BETWEEN THE MOTORPACK AND THE HANDPIECE. THE CUSTOMER ATTEMPTED TO RESTART THE CPU AND RESEAT THE MOTORPACK CONNECTION, BUT THE ISSUE PERSISTED. AS A RESULT OF THIS ISSUE, THE PROCEDURE WAS CONVERTED TO A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

THE AQUABEAM MOTORPACK WAS RETURNED FOR INVESTIGATION. THE RETURNED MOTORPACK WAS ABLE TO CONNECT TO THE QA SYSTEM BUT AN E21 WAS ENCOUNTERED. FLUID INGRESS WAS OBSERVED AFTER DISASSEMBLY OF THE MOTORPACK AND CONFIRMED TO BE THE CAUSE OF THE REPORTED EVENT. THE CAUSE OF FLUID INGRESS IS LIKELY DUE TO EXCESS STERILIZATION OF THE DEVICE AND USER HANDLING HOWEVER THE EXACT SOURCE IS UNDETERMINABLE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT NUMBER 22C03985 WAS CONDUCTED, WHICH CONFIRMED THAT THERE WERE NO NON-CONFORMANCES, FAILURES, DISCREPANCIES, OR MISSED STEPS DURING THE MANUFACTURING PROCESS THAT COULD BE RELATED TO THE REPORTED EVENT. THE REVIEW INDICATED THAT THE DEVICE MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. THE AQUABEAM USER MANUAL UM0101-00 REV. F STATES THE FOLLOWING ABOUT MOTORPACKS: 11.2.21: NOTE: AVOID PROLONGED CONTACT OF THE CLEANING OR DISINFECTANT WIPES WITH THE EXPOSED ELECTRONICS ON THE MOTORPACK CONNECTOR, AS THIS COULD LEAD TO CORROSION. 18: CONFIRM AND SECURE CONNECTION OF MOTORPACK CONNECTOR TO CONSOLE MOTORPACK RECEPTACLE. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.