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, DURING AQUABLATION THERAPY, THE PATIENT SUSTAINED AN EXTRAPERITONEAL BLADDER PERFORATION. NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED; HOWEVER, THE PATIENT DID REQUIRE PROLONGED CATHETERIZATION. THE PERFORATION WAS ATTRIBUTED TO MULTIPLE INSTANCES OF OVERTREATMENT AT THE BLADDER NECK AND INITIAL IMPROPER CATHETER PLACEMENT. THE PATIENT REMAINED STABLE AND WAS DISCHARGED FROM THE HOSPITAL. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS IDENTIFIED OR 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 DURING AQUABLATION THERAPY, PATIENT EXPERIENCED EXTRAPERITONEAL PERFORATION OF THE BLADDER. NO ADDITIONAL SURGERIES WERE REQUIRED HOWEVER THE PATIENT DID REQUIRE AN EXTENDED CATHETERIZATION. THE PERFORATION OCCURRED DUE TO OVER-TREATMENT OVER THE BLADDER NECK MULTIPLE TIMES AND THE CATHETER BEING INCORRECTLY PLACED THE FIRST TIME. THE PATIENT REMAINED STABLE AND HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL. THE HYDROS ROBOTIC SYSTEM'S UM LISTS BLADDER AND RECTAL PERFORATION AS POTENTIAL RISKS OF AQUABLATION THERAPY. BASED ON THE REVIEW OF THE INFORMATION PROVIDED, PLUS A REVIEW OF THE TREATMENT LOGS, DHR, AND UM, THE EVENT IS CONSIDERED NOT TO BE DEVICE RELATED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR 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 - 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 RECTAL INCONTINENCE OR RECTAL INJURY, INCLUDING PERFORATION. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.