AQUABEAM ROBOTIC SYSTEM

Description of Event or Problem

A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION WAS INFORMED THAT THE PATIENT INITIALLY PRESENTED WITH BLADDER STONES, WHICH WERE REMOVED PRIOR TO PROCEEDING WITH AQUABLATION. DURING THE AQUABLATION THERAPY, THE SURGEON IDENTIFIED A HIGH BLADDER NECK. FOLLOWING AQUABLATION, FBNC (FOCAL BLADDER NECK CAUTERY) WAS INITIATED, AND THE SURGEON EXPERIENCED DIFFICULTY PLACING THE RESECTOSCOPE INTO THE CHANNEL FOR AN EXTENDED PERIOD. LATER, THE SURGEON SUSPECTED THE PATIENT HAD A PERFORATED BLADDER AND DECIDED TO PERFORM AN OPEN LAPAROTOMY TO RESOLVE THE PERFORATION. THE TREATING SURGEON SUSPECTS THAT THE RESECTOSCOPE INSERTION LIKELY CAUSED THE PERFORATION. HE DOES NOT ATTRIBUTE IT TO AQUABLATION THERAPY. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED. THE PATIENT WAS REPORTED TO BE DOING WELL.

Additional Manufacturer Narrative

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. IT WAS REPORTED THAT POST AQUABLATION, FBNC (FOCAL BLADDER NECK CAUTERY) WAS INITIATED AND THE SURGEON EXPERIENCED DIFFICULTY PLACING THE RESECTOSCOPE INTO THE CHANNEL FOR AN EXTENDED PERIOD OF TIME. LATER, THE SURGEON SUSPECTED THE PATIENT HAD A PERFORATED BLADDER AND DECIDED TO PERFORM OPEN LAPAROTOMY TO RESOLVE THE PERFORATION. THE TREATING SURGEON SUSPECTS THAT THE RESECTOSCOPE INSERTION LIKELY CAUSED THE PERFORATION. HE DOES NOT ATTRIBUTE IT TO AQUABLATION THERAPY. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED. BASED ON THE INFORMATION RECEIVED, PLUS A REVIEW OF THE DHR, AND IFU, THE EVENT IS CONSIDERED NOT TO BE DEVICE RELATED. A REVIEW OF THE TREATMENT LOG FILES FOR THIS PROCEDURE COULD NOT BE CONDUCTED AS THESE WERE NOT PROVIDED. THREE GOOD FAITH EFFORTS (GFE) WERE MADE TO OBTAIN THE LOG FILES WITHOUT SUCCESS. SHALL THE LOG FILES BE MADE AVAILABLE IN THE FUTURE, THEN THIS COMPLAINT WILL BE REOPENED TO CONDUCT SUCH A REVIEW. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR AB2000-D/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 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. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.