HYDROS ROBOTIC SYSTEM

Description of Event or Problem

A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT DURING FOCAL BLADDER NECK CAUTERY, THE TRUS PROBE BECAME VISIBLE IN THE PROSTATE, INDICATING A RECTAL PERFORATION. A DIGITAL RECTAL EXAM WAS NOT PERFORMED PRIOR TO THE PROCEDURE. THE SURGEON HAD INSTILLED APPROXIMATELY 60 CC OF ULTRASOUND LUBRICANT INTO THE RECTUM AND ENCOUNTERED RESISTANCE DURING TRUS PROBE INSERTION; REPOSITIONING DID NOT RESOLVE THE RESISTANCE. DUE TO A HIGH BLADDER NECK, BLADDER VISUALIZATION WAS LIMITED AND REQUIRED REPEATED ADJUSTMENTS TO THE TRUS PROBE. AQUABLATION PROCEEDED UNTIL THE RECTAL INJURY WAS IDENTIFIED. A CATHETER WAS PLACED, GENERAL SURGERY WAS CONSULTED, AND A COLONOSCOPY CONFIRMED THE PERFORATION. THE GENERAL SURGEON RECOMMENDED AWAKENING THE PATIENT FOR IMAGING, FOLLOWED BY TEMPORARY COLOSTOMY DIVERSION. THE PATIENT HAS SINCE BEEN DISCHARGED AND IS DOING WELL. 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 CONSISTED OF REVIEW OF THE TREATMENT LOG FILES, DEVICE HISTORY RECORD (DHR) AND LABELLING. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR HY1000T/SERIAL NUMBER (B)(6) WAS PERFORMED, 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 FOR THIS EVENT WERE REVIEWED. THE 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 DO NOT USE EXCESSIVE FORCE WHEN MANIPULATING THE TRUS PROBE TO AVOID RECTAL INJURY. AS WITH ANY SURGICAL UROLOGIC PROCEDURE, POTENTIAL PERIOPERATIVE RISKS OF THE AQUABLATION PROCEDURE INCLUDE THE FOLLOWING, SOME OF WHICH MAY LED TO SERIOUS OUTCOMES AND MAY REQUIRE INTERVENTION: RECTAL INCONTINENCE OR RECTAL INJURY, INCLUDING PERFORATION. IT WAS REPORTED THAT DURING FOCAL BLADDER NECK CAUTERY, THE TRUS PROBE BECAME VISIBLE IN THE PROSTATE, INDICATING A RECTAL PERFORATION. A DIGITAL RECTAL EXAM WAS NOT PERFORMED PRIOR TO THE PROCEDURE. THE SURGEON HAD INSTILLED APPROXIMATELY 60 CC OF ULTRASOUND LUBRICANT INTO THE RECTUM AND ENCOUNTERED RESISTANCE DURING TRUS INSERTION; REPOSITIONING DID NOT RESOLVE THE RESISTANCE. DUE TO A HIGH BLADDER NECK, BLADDER VISUALIZATION WAS LIMITED AND REQUIRED REPEATED TRUS PROBE ADJUSTMENTS. AQUABLATION PROCEEDED UNTIL THE RECTAL INJURY WAS IDENTIFIED. A CATHETER WAS PLACED, GENERAL SURGERY WAS CONSULTED, AND A COLONOSCOPY CONFIRMED THE PERFORATION. THE GENERAL SURGEON RECOMMENDED AWAKENING THE PATIENT FOR IMAGING, FOLLOWED BY TEMPORARY COLOSTOMY DIVERSION. IT WAS REPORTED THAT THE PATIENT HAS SINCE BEEN DISCHARGED AND IS DOING WELL. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED. BASED ON THE INFORMATION RECEIVED, PLUS A REVIEW OF THE TREATMENT LOG FILES, DHR, AND USER MANUAL, 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.