AQUABEAM ROBOTIC SYSTEM

Additional Manufacturer Narrative

THE AQUABEAM HANDPIECE WAS NOT RETURNED FOR EVALUATION. IT WAS DISCARDED AT THE HOSPITAL. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR HANDPIECE LOT NUMBER 25C02057 AND AB2000/ SERIAL NUMBER (B)(6) WERE 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 LOG FILES FOR THIS EVENT WERE REVIEWED. HOWEVER, THE REPORTED EVENT COULD NOT BE CONFIRMED. ROOT CAUSE OF THIS EVENT REMAINS UNDETERMINABLE DUE TO THE INABILITY TO INVESTIGATE THE DEVICE. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE 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.

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 AQUABLATION THERAPY AND WHILE THE PATIENT WAS IN THE OPERATING ROOM UNDER ANESTHESIA, THE AQUABEAM ROBOTIC SYSTEM ENCOUNTERED A JET ALIGNMENT MALFUNCTION. THE ISSUE COULD NOT BE RESOLVED DESPITE MULTIPLE TROUBLESHOOTING ATTEMPTS. AS A RESULT, THE TREATING SURGEON OPTED TO ABORT THE PROCEDURE. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.