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 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 FROM (B)(6) MEDICAL CENTER FOR PROCEDURE (B)(6) 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 LEAD TO SERIOUS OUTCOMES AND MAY REQUIRE INTERVENTION: RECTAL INCONTINENCE OR RECTAL INJURY, INCLUDING PERFORATION. IT WAS REPORTED THAT DURING HEMOSTASIS, THE TREATING SURGEON NOTED VISIBILITY OF THE PROBE THROUGH THE RECTAL WALL. A URINARY CATHETER WAS PLACED, AND A SUBSEQUENT DIGITAL RECTAL EXAMINATION (DRE) INDICATED THE AREA APPEARED ACCEPTABLE. THE TREATING SURGEON CONSULTED BOTH A GENERAL SURGEON AND A COLORECTAL SURGEON, AND NO FURTHER INTERVENTION WAS DEEMED NECESSARY. CT IMAGING WAS PERFORMED FOR CONFIRMATION. THE TREATING SURGEON BELIEVES THE PATIENT¿S UNUSUAL ANATOMY (VERY SMALL PROSTATE WITH A HIGH BLADDER NECK) AND POSSIBLE TENTING WITH THE PROBE, CONTRIBUTED TO A RECTAL PERFORATION. IT WAS REPORTED THAT THE PATIENT HAS 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.

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 OBSERVED THE PROBE THROUGH THE RECTAL WALL. A URINARY CATHETER WAS PLACED, AND A SUBSEQUENT DIGITAL RECTAL EXAMINATION (DRE) INDICATED THE AREA APPEARED ACCEPTABLE. THE TREATING SURGEON CONSULTED BOTH A GENERAL SURGEON AND A COLORECTAL SURGEON, AND NO FURTHER INTERVENTION WAS DEEMED NECESSARY. CT IMAGING WAS PERFORMED FOR CONFIRMATION. THE TREATING SURGEON BELIEVES THE PATIENT¿S UNUSUAL ANATOMY (VERY SMALL PROSTATE WITH A HIGH BLADDER NECK) AND POSSIBLE TENTING WITH THE PROBE CONTRIBUTED TO A RECTAL PERFORATION. IT WAS REPORTED THAT THE PATIENT HAS BEEN DISCHARGED AND IS DOING WELL. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.