HYDROS ROBOTIC SYSTEM

Additional Manufacturer Narrative

THE HYDROS 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 DEVICE HISTORY RECORD (DHR), TREATMENT LOG FILES, AND USER MANUAL (UM). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR HY1000T-US/SERIAL NUMBER (B)(6), 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 TREATMENT SESSION LOGS WERE REVIEWED. NO INSTANCES OF ANY ERRORS WERE OBSERVED BEFORE, DURING, OR AFTER THE TREATMENT PASS AND WAS COMPLETED SUCCESSFULLY. THE HYDROS ROBOTIC SYSTEM'S USER MANUAL (UM) UM0401-00-01, US, ENGLISH, REV. C, WAS REVIEWED. 4.2.3 WARNINGS: PROCEDURE AVOID APPLYING EXCESSIVE COMPRESSION TO THE PROSTATE. EXCESSIVE COMPRESSION CAN CONTRIBUTE TO SERIOUS INJURY TO THE PATIENT. AS WITH ANY SURGICAL UROLOGIC PROCEDURE, POTENTIAL PERIOPERATIVE RISKS OF THE AQUABLATION PROCEDURE INCLUDE THE FOLLOWING, SOME OF WHICH MAY LEAD TO SERIOUS OUTCOMES AND MAY REQUIRE INTERVENTION: BLADDER OR PROSTATE CAPSULE PERFORATION. THE HYDROS 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 IDENTIFIED A BLADDER PERFORATION. THE PATIENT WAS CONVERTED TO OPEN SURGERY FOR BLADDER REPAIR. ANALYSIS FROM A CASE REVIEW CALL CONCLUDED THAT THE PERFORATION WAS ATTRIBUTABLE TO THE PATIENT¿S URINARY RETENTION, WHICH HAD RESULTED IN A WEAKENED BLADDER WALL, AND NOT RELATED TO AQUABLATION THERAPY. THE PATIENT WAS SUBSEQUENTLY DISCHARGED. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED. THE HYDROS ROBOTIC SYSTEM'S UM LISTS BLADDER PERFORATION AS A POTENTIAL RISK OF AQUABLATION THERAPY. BASED ON THE REVIEW OF THE INFORMATION PROVIDED, PLUS A REVIEW OF THE TREATMENT LOG FILES, DHR, AND UM, 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.

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 IDENTIFIED A BLADDER PERFORATION. THE PATIENT WAS CONVERTED TO OPEN SURGERY FOR BLADDER REPAIR. ANALYSIS FROM A CASE REVIEW CALL CONCLUDED THAT THE PERFORATION WAS ATTRIBUTABLE TO THE PATIENT¿S URINARY RETENTION, WHICH HAD RESULTED IN A WEAKENED BLADDER WALL, AND NOT RELATED TO THE AQUABLATION THERAPY. THE PATIENT WAS SUBSEQUENTLY DISCHARGED. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.