HYDROS ROBOTIC SYSTEM

Description of Event or Problem

A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT, POST AQUABLATION THERAPY, THE PATIENT'S ABDOMEN WAS DISTENDED. THE TREATING SURGEON HYPOTHESIZED THAT INADVERTENT CONTACT WITH THE CONTRALATERAL BLADDER WALL MAY HAVE OCCURRED DURING REPOSITIONING OF THE HYDROS HANDPIECE WHILE IDENTIFYING THE URETERAL ORIFICES (UO) AND VERUMONTANUM. SUBSEQUENTLY, THE PATIENT EXPERIENCED A BLADDER PERFORATION REQUIRING MEDICAL INTERVENTION. THE SURGEON PERFORMED A CYSTOGRAM UNDER FLUOROSCOPIC GUIDANCE, FOLLOWED BY AN ATTEMPT AT MINIMALLY INVASIVE MANAGEMENT USING THE DA VINCI SURGICAL SYSTEM; HOWEVER, CONVERSION TO AN OPEN PROCEDURE WAS ULTIMATELY NECESSARY. AS OF (B)(6) 2026, THE PATIENT HAS NOT YET BEEN DISCHARGED AND REMAINS ADMITTED DUE TO AN OPEN PROCEDURE. 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. IT WAS REPORTED THAT POST AQUABLATION THERAPY, THE PATIENT'S ABDOMEN WAS DISTENDED. THE TREATING SURGEON HYPOTHESIZED THAT INADVERTENT CONTACT WITH THE CONTRALATERAL BLADDER WALL MAY HAVE OCCURRED DURING REPOSITIONING OF THE HYDROS HANDPIECE WHILE IDENTIFYING THE URETERAL ORIFICES (UO) AND VERUMONTANUM. SUBSEQUENTLY, THE PATIENT EXPERIENCED A BLADDER PERFORATION REQUIRING MEDICAL INTERVENTION. THE SURGEON PERFORMED A CYSTOGRAM UNDER FLUOROSCOPIC GUIDANCE, FOLLOWED BY AN ATTEMPT AT MINIMALLY INVASIVE MANAGEMENT USING THE DA VINCI SURGICAL SYSTEM; HOWEVER, CONVERSION TO AN OPEN PROCEDURE WAS ULTIMATELY NECESSARY. AS OF (B)(6) 2026, THE PATIENT HAS NOT YET BEEN DISCHARGED AND REMAINS ADMITTED DUE TO AN OPEN PROCEDURE. 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 BUT USER ERROR. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR HYDROS ROBOTIC SYSTEM; HY1000-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 HYDROS 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 HYDROS ROBOTIC SYSTEM'S USER MANUAL (UM) UM0401-00-01, US, ENGLISH, 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. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.