HYDROS ROBOTIC SYSTEM

Additional Manufacturer Narrative

THE RETURNED MOTORPACK WAS VISUALLY INSPECTED WITH NO OBSERVED DAMAGE. THE MOTORPACK WAS ADDITIONALLY ABLE TO BE SUCCESSFULLY CONNECTED TO THE SYSTEM WITH A DOCKED HANDPIECE AND JOGGED. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED AND THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL. NO PROBLEM WAS FOUND. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR HY1000/SERIAL NUMBER (B)(6) AND HYDROS MOTORPACK/LOT NUMBER 25C00925 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 FAILURE. THE REVIEW INDICATED THAT THE DEVICE MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. UM0401-00-01 REV C HYDROS ROBOTIC SYSTEM USER MANUAL WAS REVIEWED: 4.3.1: DO NOT ALLOW FLUID CONTAMINANT TO CONTACT THE MOTORPACK CONNECTOR OR DOCKING SWITCH, AS THIS MAY CAUSE ACCELERATED CORROSION OF THE MOTORPACK'S EXPOSED METALLIC PARTS. 4.3.2: CHECK THAT THE HANDPIECE-TO-MOTORPACK CONNECTION IS COMPLETELY TAPED. AN INCOMPLETE SEAL COULD LEAD TO FLUID INGRESS, POTENTIALLY DAMAGING THE HANDPIECE OR MOTORPACK. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

Additional Manufacturer Narrative

COMPONENT CODE = 4756 - HYDROS MOTORPACK, A REUSABLE COMPONENT OF THE HYDROS 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 WAS NOTIFIED OF AN ISSUE DURING PROCEDURAL SETUP. WHILE THE PATIENT WAS UNDER ANESTHESIA IN THE OPERATING ROOM, THE HYDROS MOTORPACK WAS NOT REGISTERING AND WOULD NOT ALLOW PROPER CONNECTIVITY. AS A RESULT, THE PROCEDURE WAS ABORTED. THERE WERE NO ADVERSE HEALTH CONSEQUENCES FOR THE PATIENT AS A RESULT OF THIS EVENT.