AQUABEAM ROBOTIC SYSTEM

Description of Event or Problem

A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT DURING HEMOSTASIS, THE TREATING SURGEON OBSERVED A POSSIBLE BLADDER AND RECTAL INJURY CAUSED BY THE BIPOLAR LOOP. UPON REMOVAL OF THE TRANSRECTAL ULTRASOUND (TRUS) PROBE, BURN MARKS WERE NOTED ON THE DISTAL ARRAYS OF THE PROBE. FOLLOWING THE PROCEDURE, THE TREATING SURGEON REFERRED THE PATIENT TO GENERAL SURGERY, WHERE EVALUATION CONFIRMED BLADDER AND RECTAL INJURIES. THE GENERAL SURGEON PERFORMED SURGICAL REPAIR OF BOTH THE BLADDER AND RECTUM. THE PATIENT HAS SINCE BEEN DISCHARGED AND IS REPORTED TO BE DOING WELL. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

Additional Manufacturer Narrative

THE AQUABEAM ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS STILL CURRENTLY IN POSSESSION OF THE USER FACILITY. THE INVESTIGATION OF THIS EVENT CONSISTED OF A REVIEW OF THE DEVICE HISTORY RECORD (DHR), AND INSTRUCTIONS FOR USE (IFU). 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 SYSTEM 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. AS WITH ANY SURGICAL UROLOGIC PROCEDURE, POTENTIAL PERIOPERATIVE RISKS OF THE AQUABLATION PROCEDURE INCLUDE: BLADDER OR PROSTATE CAPSULE PERFORATION RECTAL INCONTINENCE / PERFORATION. A REVIEW OF THE 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. THE AQUABEAM ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS STILL CURRENTLY IN POSSESSION OF THE USER FACILITY. IT WAS REPORTED THAT DURING HEMOSTASIS, THE TREATING SURGEON OBSERVED A POSSIBLE BLADDER AND RECTAL INJURY CAUSED BY THE BIPOLAR LOOP. UPON REMOVAL OF THE TRANSRECTAL ULTRASOUND (TRUS) PROBE, BURN MARKS WERE NOTED ON THE DISTAL ARRAYS OF THE PROBE. FOLLOWING THE PROCEDURE, THE TREATING SURGEON REFERRED THE PATIENT TO GENERAL SURGERY, WHERE EVALUATION CONFIRMED BLADDER AND RECTAL INJURIES. THE GENERAL SURGEON PERFORMED SURGICAL REPAIR OF BOTH THE BLADDER AND RECTUM. THE PATIENT HAS SINCE BEEN DISCHARGED AND IS REPORTED TO BE DOING WELL. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED. BASED ON THE INFORMATION PROVIDED, PLUS A REVIEW OF THE DHR, AND IFU THE EVENT IS CONSIDERED NOT TO BE DEVICE RELATED. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.