HYDROS ROBOTIC SYSTEM

Additional Manufacturer Narrative

COMPONENT CODE = 4756; HYDROS MOTORPACK, A RE-USABLE COMPONENT OF THE HYDROS ROBOTIC SYSTEM DESIGNED TO DOCK WITH THE DISPOSABLE HYDROS HANDPIECE. 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 HYDROS ROBOTIC SYSTEM MOTORPACK COULD NOT BE PLUGGED INTO THE HYDROS TOWER DESPITE TROUBLESHOOTING ATTEMPTS. THE REPORTED EVENT CAUSED THE PROCEDURE TO BE ABORTED. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

Additional Manufacturer Narrative

HYDROS ROBOTIC SYSTEM MOTORPACK WAS RETURNED FOR EVALUATION. THE RETURNED MOTORPACK WAS VISUALLY INSPECTED AND THE DAMAGE TO THE CONNECTOR CABLE WAS OBSERVED. THE RETURNED MOTORPACK WAS UNABLE TO CONNECT TO THE TEST HYDROS SYSTEM BECAUSE THE CONNECTOR CABLE WAS DAMAGED. THE REPORTED EVENT WAS CONFIRMED, HOWEVER THE ROOT CAUSE OF THE CABLE DAMAGE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR MOTORPACK LOT NUMBER 24C05088 AND HY1000T/ SERIAL NUMBER (B)(6) 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. HYDROS ROBOTIC SYSTEM USER MANUAL UM0401-00-01 REV C WAS REVIEWED: 4.2.3: INCOMPLETE ENGAGEMENT OF THE MAGNETIC LATCH COULD CAUSE PATIENT OR USER INJURY DUE TO UNANTICIPATED MOVEMENT OF THE MOTORPACK AND HANDPIECE. ENSURE THE MOTORPACK STRIKE PLATE IS CORRECTLY POSITIONED AGAINST THE MAGNETIC BLOCK AND THAT THE MAGNETIC LATCH SWITCH IS POINTING TOWARDS THE BLACK INDICATOR IN THE ¿ON¿ POSITION. 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. 10.2: CAUTION: 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. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.