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 THE PATIENT SUSTAINED A BLADDER PERFORATION. DUE TO A TIGHT URETHRA AND A HIGH BLADDER NECK, THE TREATING SURGEON SLIGHTLY LOWERED THE TRUS PROBE TO ALLOW ENTRY OF THE AQUABEAM HANDPIECE. THIS INADVERTENTLY CAUSED THE AQUABEAM HANDPIECE TO ADVANCE DIRECTLY THROUGH THE BLADDER WALL, RESULTING IN THE PERFORATION. A URINARY CATHETER WAS INSERTED, AND THE TREATING SURGEON NOTED THAT THE PERFORATION WOULD HEAL WITH CONSERVATIVE MANAGEMENT. NO INTERVENTIONS OR SURGERIES WERE PERFORMED, AND THE PATIENT HAS SINCE BEEN DISCHARGED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

Additional Manufacturer Narrative

THE AQUABEAM ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS CURRENTLY IN THE POSSESSION OF THE USER FACILITY. THE INVESTIGATION OF THIS EVENT CONSISTED OF A REVIEW OF THE TREATMENT LOG FILES, DEVICE HISTORY RECORD (DHR), AND INSTRUCTIONS FOR USE (IFU). THE AQUABEAM ROBOTIC SYSTEM'S TREATMENT LOG FILES WERE REVIEWED, WHICH CONFIRMED NO MALFUNCTION OCCURRED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR AB2000/SERIAL NUMBER 22C01961 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 INSTRUCTION FOR USE (IFU), IFU0104-00, REV. C, WAS REVIEWED. 4.3 WARNINGS: PROCEDURE. AS WITH ANY SURGICAL UROLOGIC PROCEDURE, POTENTIAL PERIOPERATIVE RISKS OF THE AQUABLATION PROCEDURE INCLUDE BUT ARE NOT LIMITED TO THE FOLLOWING, SOME OF WHICH MAY LEAD TO SERIOUS OUTCOMES AND MAY REQUIRE INTERVENTION: 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. IT WAS REPORTED THAT THE BLADDER PERFORATION WAS INADVERTENTLY CAUSED BY THE TREATING SURGEON. NO INTERVENTIONS OR SURGERIES WERE PERFORMED AND THE PATIENT HAS SINCE BEEN DISCHARGED. BASED ON THE INFORMATION PROVIDED, PLUS A REVIEW OF THE TREATMENT LOG FILES, 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.