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 THE PATIENT SUSTAINED A RECTAL INJURY. IT WAS REPORTED THAT BLOOD WAS OBSERVED UPON RETRACTING THE TRUS PROBE. AN EXAMINATION REVEALED A SMALL TEAR AT THE ANAL OPENING. THE TEAR WAS PACKED AND THE PATIENT WAS PRESCRIBED WITH LOCAL ANESTHETICS. NO ADDITIONAL MEDICAL INTERVENTIONS OR SURGERIES WERE PERFORMED. A COMBINATION OF THE PATIENT'S ANATOMY, PRE-EXISTING HEMORRHOIDAL TISSUE, AND PRONOUNCED ADJUSTMENT OF THE TRUS PROBE LIKELY CAUSED THE TEAR. THE PATIENT WAS REPORTED TO BE 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 CURRENTLY IN THE POSSESSION OF THE USER FACILITY. THE INVESTIGATION OF THIS EVENT CONSISTED OF A REVIEW OF THE TREATMENT LOG FILES, DEVICE HISTORY RECORD (DHR), AND USER MANUAL (UM). 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. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR HY1000/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 USER MANUAL (UM) UM0401-00-01, 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: RECTAL 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 UM LISTS RECTAL INJURY AS A POTENTIAL RISK OF AQUABLATION THERAPY. A SMALL TEAR WAS OBSERVED AT THE PATIENT'S ANAL OPENING. THE TEAR WAS PACKED AND THE PATIENT WAS PRESCRIBED WITH LOCAL ANESTHETICS. NO ADDITIONAL MEDICAL INTERVENTIONS OR SURGERIES WERE PERFORMED. A COMBINATION OF THE PATIENT'S ANATOMY, PRE-EXISTING HEMORRHOIDAL TISSUE, AND PRONOUNCED ADJUSTMENT OF THE TRUS PROBE LIKELY CAUSED THE TEAR. THE PATIENT IS DOING WELL. BASED ON THE ADDITIONAL INFORMATION PROVIDED, PLUS A REVIEW OF THE TREATMENT LOG FILES, DHR, AND UM, 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.