HYDROS ROBOTIC SYSTEM

Additional Manufacturer Narrative

COMPONENT CODE = 4756 - AQUABEAM FOOT PEDAL, A REUSABLE COMPONENT OF THE AQUABEAM ROBOTIC SYSTEM, USED TO ALIGN AND ACTIVATE THE HIGH-VELOCITY WATERJET DURING AQUABLATION TREATMENT. 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 PROCEDURAL SETUP AND WHILE THE PATIENT WAS IN THE OPERATING ROOM (OR) UNDER ANESTHESIA, THE HYDROS FOOT PEDAL SWITCH WAS FOUND TO BE INOPERABLE. DUE TO THIS MALFUNCTION, THE SURGEON ELECTED TO ABORT THE PROCEDURE AND RESCHEDULE FOR A LATER DATE. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

Additional Manufacturer Narrative

CORRECTION TO COMPONENT CODE = 4756. COMPONENT CODE = 4756 - HYDROS FOOT PEDAL, A RE-USABLE COMPONENT OF THE HYDROS ROBOTIC SYSTEM, USED TO ALIGN AND ACTIVATE THE HIGH-VELOCITY WATERJET DURING AQUABLATION TREATMENT. THE HYDROS FOOT PEDAL WAS RETURNED FOR INVESTIGATION. DURING FUNCTIONING TESTING, THE REPORTED FAILURE COULD NOT BE REPRODUCED AS THE HYDROS FOOT PEDAL WAS FOUND TO BE FUNCTIONING AS INTENDED. THE ROOT CAUSE SOURCE WAS UNABLE TO BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR HY1000/SERIAL NUMBER (B)(6) AND HYDROS FOOT PEDAL/LOT NUMBER 24C04434 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 ROBOTIC SYSTEM'S USER MANUAL, UM0401-00-01, REV. C, WAS REVIEWED. SECTION 6.7: THE HYDROS FOOT PEDAL, A RE-USABLE COMPONENT OF THE HYDROS ROBOTIC SYSTEM, CONTAINS THREE FOOT ACTIVATED BUTTONS. THE AQUABLATE PEDAL IS THE LARGE CENTER BUTTON WHICH MUST BE DEPRESSED TO ENABLE THE AQUABLATION TREATMENT. DEPRESSING THE AQUABLATE PEDAL ONLY ACTIVATES THE HIGH-VELOCITY WATERJET DURING TREAT MODE. THE AQUABLATE PEDAL IS ALSO USED TO ACTIVATE THE WATERJET AT LOWER POWER TO HELP IDENTIFY THE NOZZLE POSITION DURING THE ALIGNMENT STEPS. THE TWO SMALLER BUTTONS AT TOP LEFT AND TOP RIGHT PROVIDE CONTROLS FOR PRIMING AND MANUAL ASPIRATION. THE FOOT PEDAL IS CONNECTED TO THE TOWER WITH A FLEXIBLE CABLE, BY WHICH THE USER INPUT IS TRANSMITTED. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.