HYDROS ROBOTIC SYSTEM

Description of Event or Problem

A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT DURING AQUABLATION THERAPY, THE PATIENT'S BLADDER NECK WAS UNDERMINED. THE PATIENT'S URETERAL ORIFICES (UOS) WERE INTACT BUT VERY CLOSE TO THE UNDERMINED BLADDER NECK REGION. THE TREATING SURGEON DECIDED TO MOVE FORWARD WITH PLACING PRECAUTIONARY STENTS. THE PATIENT IS RECOVERING NORMALLY AND WILL BE REASSESSED FOR STENT REMOVAL IN ONE MONTH. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.

Additional Manufacturer Narrative

THE HYDROS ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS STILL CURRENTLY IN POSSESSION OF THE USER FACILITY. THE INVESTIGATION CONSISTS OF INFORMATION RECEIVED, PLUS REVIEW OF THE TREATMENT LOGS, AND LABELING. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR HY1000/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 LOG FILES WERE REVIEWED. NO INSTANCES OF ANY ERRORS WERE OBSERVED BEFORE, DURING, OR AFTER THE TREATMENT PASS, WHICH WAS COMPLETED SUCCESSFULLY. THE HYDROS ROBOTIC SYSTEM'S USER MANUAL (UM), UM0401-00-01, REV. C, WAS REVIEWED. 4.2.3 WARNINGS: PROCEDURE 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. ALTHOUGH THE HYDROS ROBOTIC SYSTEM'S LABELING DOES NOT SPECIFICALLY MENTION DAMAGE TO URETERAL ORIFICES, PROCEPT'S RISK MANAGEMENT DOCUMENTATION INCLUDES DAMAGE TO URETERAL ORIFICES AS A CLINICAL EFFECT OF AQUABLATION THERAPY. THE HYDROS ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS STILL CURRENTLY IN POSSESSION OF THE USER FACILITY. IT WAS REPORTED THAT DURING AQUABLATION THERAPY, THERE WAS UNDERMINING OF THE PATIENT'S BLADDER NECK. THE PATIENT'S URETERAL ORIFICES REMAINED INTACT. THE TREATING SURGEON DECIDED TO MOVE FORWARD PLACING PRECAUTIONARY STENTS. THE PATIENT HAS SINCE BEEN DISCHARGED AND WILL BE REASSESSED FOR STENT REMOVAL IN A MONTH. THE HYDROS ROBOTIC SYSTEM'S UM LISTS BLADDER OR PROSTATE CAPSULE PERFORATION AS A POTENTIAL RISKS OF AQUABLATION THERAPY. ALTHOUGH THE HYDROS ROBOTIC SYSTEM'S LABELING DOES NOT SPECIFICALLY MENTION DAMAGE TO URETERAL ORIFICES, PROCEPT'S RISK MANAGEMENT DOCUMENTATION INCLUDES DAMAGE TO URETERAL ORIFICES AS A CLINICAL EFFECT OF AQUABLATION THERAPY. BASED ON THE INFORMATION RECEIVED, PLUS A REVIEW OF THE TREATMENT LOG FILES, DHR, IFU, AND RISK DOCUMENTATION, 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.