AQUABEAM ROBOTIC SYSTEM

Description of Event or Problem

A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS INC. (PROCEPT) BECAME AWARE THAT, DURING ROUTINE FOLLOW-UP, THE PATIENT PRESENTED WITH URINARY RETENTION THE DAY AFTER AQUABLATION THERAPY. IT WAS DETERMINED THAT A RESIDUAL FLAP OF TISSUE FROM THE MEDIAN LOBE REMAINED. THE SURGEON CONCLUDED THAT GREATER PRESERVATION OF THE MEDIAN LOBE DURING FOCAL BLADDER NECK CAUTERY (FBNC) WOULD HAVE BEEN APPROPRIATE. THUS, THE URINARY RETENTION WAS NOT DIRECTLY ATTRIBUTABLE TO AQUABLATION, BUT RATHER INADEQUATE HEMOSTASIS RESECTION. A BRIEF TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) WAS GIVEN TO REMOVE THE REMAINING MEDIAN LOBE TISSUE. PATIENT IS WELL AND HAS 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 OF LOGS, DEVICE HISTORY RECORD (DHR), AND INSTRUCTIONS FOR USE (IFU). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED 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 SYSTEM MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. THE AQUABEAM ROBOTIC SYSTEM'S TREATMENT LOG FILE WAS REVIEWED, WHICH CONFIRMED NO MALFUNCTIONS DURING THE AQUABLATION PROCEDURE AND INDICATED THAT THE SYSTEM FUNCTIONED AS DESIGNED. THE AQUABEAM ROBOTIC SYSTEM'S INSTRUCTION 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: URINARY RETENTION. THE AQUABEAM ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS STILL CURRENTLY IN POSSESSION OF THE USER FACILITY. IT WAS REPORTED THAT DURING ROUTINE FOLLOW UP, THE PATIENT PASSED THE VOID TRIAL; HOWEVER, LATER THAT DAY THE PATIENT EXPERIENCED URINARY RETENTION. IT TURNED OUT THAT THERE WAS A REMAINING FLAP OF TISSUE FROM THE MEDIAN LOBE. THE SURGEON CONCLUDED THAT HE SHOULD HAVE RESPECTED MORE OF THE MEDIAN LOBE DURING FOCAL BLADDER NECK CAUTERY (FBNC). SO WHILE THE RETENTION WASN'T A RESULT OF AQUABLATION THERAPY SPECIFICALLY, IT WAS CAUSED BY INADEQUATE HEMOSTASIS RESECTION. THE ROOT CAUSE WAS DETERMINED TO BE USER ERROR. A BRIEF TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) WAS GIVEN TO REMOVE THE REMAINING MEDIAN LOBE TISSUE. PATIENT IS WELL AND HAS BEEN DISCHARGED. THE AQUABEAM ROBOTIC SYSTEM'S IFU LISTS URINARY RETENTION AS POTENTIAL RISKS OF AQUABLATION THERAPY. BASED ON THE REVIEW OF 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.