AQUABEAM ROBOTIC SYSTEM

Additional Manufacturer Narrative

THE AQUABEAM ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS STILL CURRENTLY IN POSSESSION OF THE USER FACILITY. THE INVESTIGATION CONSISTS OF REVIEW OF DEVICE HISTORY RECORD (DHR), TREATMENT LOG FILES, AND LABELLING. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR AB2000-B/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 LOG FILES OF THIS EVENT WERE REVIEWED. NO INSTANCES OF ANY ERRORS WERE OBSERVED BEFORE, DURING, OR AFTER THE TREATMENT PASS AND WAS COMPLETED SUCCESSFULLY. THE AQUABEAM ROBOTIC SYSTEM'S INSTRUCTIONS FOR USE (IFU), IFU0101-00, REV. E, WAS REVIEWED. 4.3. WARNINGS: PROCEDURE: AS WITH ANY SURGICAL UROLOGIC PROCEDURE, POTENTIAL PERIOPERATIVE RISKS OF THE AQUABLATION PROCEDURE INCLUDE: BLADDER OR PROSTATE CAPSULE PERFORATION. THE AQUABEAM ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS STILL CURRENTLY IN POSSESSION OF THE USER FACILITY. THE AQUABEAM ROBOTIC SYSTEM'S IFU LISTS BLADDER PERFORATION AS A POTENTIAL RISK OF AQUABLATION THERAPY. BASED ON THE INFORMATION RECEIVED, PLUS A REVIEW OF THE TREATMENT LOG FILES, DHR, AND IFU, THE EVENT IS CONSIDERED NOT TO BE DEVICE RELATED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED. 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 INFORMED THAT DURING THE AQUABLATION THERAPY, THE SURGEON IDENTIFIED A BLADDER DIVERTICULUM AND A SIGNIFICANTLY HIGH MEDIAN LOBE OF THE PROSTATE. AS THE HANDPIECE WAS ADVANCED INTO THE PATIENT, THE SURGEON, NOT RECOGNIZING THE RESISTANCE, PUSHED THE TIP OF THE HANDPIECE THROUGH THE BLADDER WALL. THE BLADDER PERFORATION WAS IMMEDIATELY IDENTIFIED BY THE TREATING SURGEON AND WAS REPAIRED WITH DIATHERMY. THE TREATING SURGEON ELECTED TO ABORT THE PROCEDURE AND WAIT UNTIL THE PATIENT'S BLADDER HEALS TO PERFORM AQUABLATION. THE PATIENT WAS REPORTED TO BE DOING WELL AND WAS DISCHARGED THE NEXT DAY. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.