HYDROS ROBOTIC SYSTEM

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 IMAGE WAS NOT DISPLAYING AS USUAL ON THE HYDROS ROBOTIC SYSTEM. IMAGE SETTINGS WERE ADJUSTED TO IMPROVE IMAGING; HOWEVER, THE SCREEN STILL APPEARED BLACK, WITH VERY FAINT SPECKLED NOISE VISIBLE. THE TRUS PROBE CONNECTION WAS NOT LOCKING INTO THE HYDROS ROBOTIC SYSTEM. TROUBLESHOOTING WAS ATTEMPTED, BUT THE ISSUE PERSISTED. 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

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.

Additional Manufacturer Narrative

THE HYDROS ULTRASOUND ENGINE MODULE WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION AND FUNCTIONAL TESTING CONFIRMED THAT THE LATCHING MECHANISM WAS DAMAGED. FURTHER FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE INABILITY TO CONNECT A PROBE. THE ROOT CAUSE OF THE REPORTED FAILURE IS USER ERROR. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR HY1000/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. THE HYDROS ROBOTIC SYSTEM'S USER MANUAL (UM), UM0401-00-01, REV. C, WAS REVIEWED. CAREFULLY CONNECT TRUS PROBE WITH CABLE TO THE LEFT AND SECURE BY PRESSING THE CONNECTOR LEVER DOWN. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.