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), EVENT HISTORY LOG REVIEW AND THE 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 CONDUCTED, 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), (B)(4) 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: O BLEEDING OR BLOOD IN URINE. SECTION 9: POST-OP STERILE, HEMOSTASIS STATES THE FOLLOWING: PRIOR TO INTRODUCING THE RESECTOSCOPE TO START HEMOSTASIS, REDUCE TRUS COMPRESSION AND ENSURE THERE IS NO STEEP ANGLING OF THE TRUS PROBE. NOTE: DEPENDING ON PATIENT ANATOMY, CONSIDER THAT TRUS PROBE MAY BE REMOVED ENTIRELY, IF NEEDED TO MANIPULATE THE RESECTOSCOPE ADEQUATELY FOR HEMOSTASIS. WARNING: AVOID APPLYING EXCESSIVE COMPRESSION TO THE PROSTATE. EXCESSIVE COMPRESSION CAN CONTRIBUTE TO SERIOUS INJURY TO THE PATIENT. PREPARE THE RESECTOSCOPE AND TOOMEY SYRINGE/CLOT EVACUATOR FOR HEMOSTASIS. INTRODUCE RESECTOSCOPE SHEATH. EVACUATE CLOTS WITH TOOMEY OR ELLIK EVACUATOR. CAUTION: POSITION THE ELECTROSURGICAL GENERATOR APART FROM THE HYDROS ROBOTIC SYSTEM, AS PERMITTED BY THE OPERATING ROOM LAYOUT. USE A LOOP TO SYSTEMATICALLY WORK AROUND THE BLADDER NECK AND REMOVE THE ¿FLUFFY¿ TISSUE (TISSUE DEVITALIZED BY AQUABLATION THERAPY) TO VIEW POTENTIAL BLEEDING VESSELS UNDERNEATH. PERFORM FOCAL CAUTERY AT BLEEDERS. TURN OFF IRRIGATION AND INSPECT FOR BLEEDERS UNDER NORMAL BLOOD PRESSURE. NOTE: ALTERNATE HEMOSTASIS METHODS MAY INCLUDE: - BALLOON CATHETER IN BLADDER WITH BLADDER NECK TRACTION. - BALLOON CATHETER IN BLADDER WITH BLADDER NECK TRACTION. FILL THE BLADDER WITH STERILE SALINE AND MAINTAIN FOR 30-60 MINUTES BEFORE STARTING CBI. UNDER SPINAL ANESTHESIA. - BALLOON CATHETER IN BLADDER, NO TRACTION. - BALLOON CATHETER IN PROSTATIC FOSSA. - INFLATE BALLOON WITH 5CC SALINE IN THE BLADDER. - RETRACT BALLOON UNDER TRUS GUIDANCE INTO PROSTATIC FOSSA. - INFLATE BALLOON TO 30-50% OF THE INITIAL PROSTATE VOLUME. - APPLY MILD TRACTION TO HOLD THE BALLOON CATHETER IN PLACE. ONCE HEMOSTASIS IS ACHIEVED, REMOVE TRUS PROBE AND INSPECT PROBE AND ANUS FOR BLOOD AND INVESTIGATE, AS NEEDED. INTRODUCE 22-24F HEMATURIA CATHETER, INFLATE BALLOON, AND APPLY STANDARD TO LIGHT TRACTION AS NEEDED. RUN CBI PER FACILITY'S TURP PROTOCOL. MONITOR IRRIGATION BAGS TO MAINTAIN FLUID SUPPLY. MONITOR EFFLUENT COLOR. WARNING: UNADDRESSED VASCULAR BLEEDING CAN LEAD TO SERIOUS PATIENT HARM. 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 LISTS BLEEDING AS A POTENTIAL RISK OF AQUABLATION THERAPY AND PROVIDES ADEQUATE INSTRUCTIONS ON HOW TO ACHIEVE APPROPRIATE HEMOSTASIS. BASED ON THE REVIEW OF THE 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.

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 PATIENT WAS BLEEDING AND TAKEN BACK INTO THE OPERATING ROOM FOR CAUTERIZATION TO ACHIEVE HEMOSTASIS. THE TREATING SURGEON DID NOT REPORT ANY ISSUES AND THE PATIENT IS DOING WELL AND HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.