AQUABEAM ROBOTIC SYSTEM

Additional Manufacturer Narrative

THE AQUABEAM CONSOLE WAS RETURNED FOR INVESTIGATION. THE TREATMENT LOG FILES WERE NOT REVIEWED AS THEY WERE NOT MADE AVAILABLE. DURING FUNCTIONAL TESTING, THE AQUABEAM CONSOLE TRIGGERED AN ERROR WHICH COULD NOT BE CLEARED. IT IS LIKELY THAT THE REPORTED FAILURE OCCURRED DUE TO A DEFECTIVE COMPONENT. THE ROOT CAUSE OF THE REPORTED FAILURE WAS UNABLE TO BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR AB2000/SERIAL NUMBER (B)(6) AND AQUABEAM CONSOLE/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 FAILURE. THE REVIEW INDICATED THAT THE DEVICE MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. THE AQUABEAM ROBOTIC SYSTEM'S USER MANUAL (UM), SJ-UM0101-00, REV. C, WAS REVIEWED. TABLE 5 STATES BELOW. E03 ¿ CONSOLE ERROR. RELEASE FOOT PEDAL AND CLICK X. IF ERROR PERSISTS, TURN OFF AND TURN ON CONSOLE. 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 - AQUABEAM CONSOLE, A REUSABLE COMPONENT OF THE AQUABEAM ROBOTIC SYSTEM. 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 (OR) UNDER ANESTHESIA, THE AQUABEAM CONSOLE DISPLAYED "E03 - CONSOLE ERROR" CODE. TROUBLESHOOTING EFFORTS INCLUDED VERIFYING ALL CONNECTIONS, UNPLUGGING AND RE-PLUGGING CORDS, AND REBOOTING. HOWEVER, DESPITE THESE EFFORTS, THE AQUABEAM CONSOLE REMAINED UNRESPONSIVE AND DID NOT POWER ON FOLLOWING THE ERROR. DUE TO THE AQUABEAM CONSOLE MALFUNCTION, THE SURGEON CONVERTED THE PROCEDURE TO A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). THERE WERE NO ADVERSE HEALTH EFFECTS EXPERIENCED BY THE PATIENT AS A RESULT OF THIS EVENT.