HYDROS ROBOTIC SYSTEM

Additional Manufacturer Narrative

COMPONENT CODE = 4756 - THE HANDPIECE ARM, A RE-USABLE COMPONENT OF THE HYDROS ROBOTIC SYSTEM, FIXES THE MOTORPACK/HYDROS HANDPIECE ASSEMBLY IN POSITION RELATIVE TO THE PATIENT. 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 WAS SCHEDULED FOR AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT DURING THE SETUP OF AQUABLATION THERAPY AND WHILE THE PATIENT WAS IN THE OPERATING ROOM UNDER ANESTHESIA, THE EDGE OF THE BED CAUGHT THE HYDROS ROBOTIC SYSTEM HANDPIECE (HP) ARM, CAUSING IT TO BREAK THE MAGNETIC BLOCK ON THE AQUABEAM MOTORPACK INTO SEVERAL PIECES. THE REPORTED EVENT CAUSED THE PROCEDURE TO BE ABORTED. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

THE HYDROS MAG BLOCK WAS NOT RETURNED FOR INVESTIGATION. THREE (3) GOOD FAITH EFFORTS WERE MADE BY PROCEPT TO RETRIEVE THE MAG BLOCK WITHOUT SUCCESS. THE ROOT CAUSE OF THE REPORTED EVENT IS USER BASED ON THE EVENT DESCRIPTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT NUMBER 24C04623 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 HYDROS UM0401-00 REV. C USER MANUAL, ENGLISH STATES THE FOLLOWING IN SECTION 4.3.2 HANDLE THE DEVICE COMPONENTS WITH CARE TO AVOID DROPPING OR OTHERWISE DAMAGING THEM DURING SETUP. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.