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 OF THIS EVENT CONSISTED OF A REVIEW OF THE DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU) AND TREATMENT LOGS FILES. 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 HYDROS ROBOTIC SYSTEM'S TREATMENT LOG FILES WERE REVIEWED, WHICH CONFIRMED NO MALFUNCTION OCCURRED. THE REVIEW OF THE TREATMENT LOG FILES REVEALED THAT THE HYDROS ROBOTIC SYSTEM FUNCTIONED AS INTENDED, AS NO MALFUNCTION WAS OBSERVED DURING AQUABLATION THERAPY. 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 THE HYDROS ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS STILL CURRENTLY IN POSSESSION OF THE USER FACILITY. THE HYDROS ROBOTIC SYSTEM'S USER MANUAL (UM) LISTS RECTAL PERFORATION AS A POTENTIAL RISK OF AQUABLATION THERAPY. BASED ON THE REVIEW OF THE INFORMATION PROVIDED, THE TREATMENT LOG FILES, DHR, AND UM, THE EVENT IS CONSIDERED NOT TO BE DEVICE RELATED.

Additional Manufacturer Narrative

ROOT CAUSE OF THE REPORTED EVENT HAS NOT YET BEEN ESTABLISHED. INVESTIGATION BY MANUFACTURER IS CURRENTLY IN PROCESS. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. H3 OTHER TEXT : THE HYDROS ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS STILL CURRENTLY IN POSSESSION OF THE USER FACILITY.

Description of Event or Problem

A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT, POST-AQUABLATION THERAPY, THE TREATING SURGEON NOTED A POSSIBLE PERFORATION OF THE BOWEL AFTER REMOVAL OF THE TRUS PROBE. THE CASE WAS CONVERTED TO A DIVERTING COLOSTOMY USING THE DA VINCI SURGICAL SYSTEM. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL DETAILS ABOUT THIS EVENT; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.