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), TREATMENT LOG FILES AND INSTRUCTIONS FOR USE (IFU). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR HY1000-US/SERIAL NUMBER: (B)(6) WAS CONDUCTED, WHICH CONFIRMED THAT THERE WERE NO NON-CONFORMANCE'S, FAILURES, DISCREPANCIES, OR MISSED STEPS DURING THE MANUFACTURING PROCESS THAT COULD BE RELATED TO THE REPORTED EVENT. THE REVIEW INDICATED THAT THE SYSTEM MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. THE LOG FILES WERE REVIEWED. NO INSTANCES OF ANY ERRORS WERE OBSERVED BEFORE, DURING, OR AFTER THE TREATMENT PASS, WHICH WAS COMPLETED SUCCESSFULLY. THE HYDROS ROBOTIC SYSTEM'S USER MANUAL (UM) UM0401-00-01 REV. C, WAS REVIEWED. 3. CONTRAINDICATIONS: DO NOT USE THE HYDROS ROBOTIC SYSTEM IN PATIENTS WHO DO NOT MEET THE INDICATION FOR THE SYSTEM¿S INTENDED USE. 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: BLADDER OR PROSTATE CAPSULE PERFORATION. BLEEDING OR BLOOD IN THE URINE. 4.2.3 WARNINGS: PROCEDURE: AVOID APPLYING EXCESSIVE COMPRESSION TO THE PROSTATE. EXCESSIVE COMPRESSION CAN CONTRIBUTE TO SERIOUS INJURY TO THE PATIENT. AN OVERLY FULL BLADDER CAN INTERACT WITH THE RECTAL ANATOMY TO CREATE MORE RESISTANCE TO ADVANCING THE TRUS STEPPER AFTER MID-PROSTATE ANGLE PLANNING. IF THE TRUS PROBE IS ADVANCED THROUGH TISSUE RESISTANCE, IT COULD POTENTIALLY CONTRIBUTE TO SERIOUS PATIENT INJURY, SUCH AS RECTAL PERFORATION. IF THE BLADDER IS OVERLY FULL, ASPIRATE TO REDUCE THE FLUID LEVEL IN THE BLADDER PRIOR TO CONTINUING WITH THE PROCEDURE. 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 TREATING SURGEON DOES NOT ATTRIBUTE THIS EVENT TO AQUABLATION. THE HYDROS ROBOTIC SYSTEM'S UM LISTS PROSTATE CAPSULE PERFORATION AND BLEEDING AS POTENTIAL RISKS OF AQUABLATION THERAPY. BASED ON 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 CORPORATION (PROCEPT) BECAME AWARE THAT, FOLLOWING AQUABLATION THERAPY, THE PATIENT WAS BLEEDING AND REQUIRED RETURN TO THE OPERATING ROOM. THE SOURCE OF BLEEDING NEEDED TO BE IDENTIFIED; HOWEVER, THE PATIENT NEEDED TO BE RESUSCITATED IN THE OPERATING ROOM DUE TO A LOSS OF BLOOD AND SUBSEQUENT CARDIAC ARREST. IT WAS DETERMINED THAT THE PATIENT'S PROSTATE CAPSULE RUPTURED. THE PATIENT HAD BEEN SCOPED AT THE END OF THE AQUABLATION THERAPY, AND THERE WERE NO SIGNS OF PROSTATE CAPSULE RUPTURE. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM AND RECEIVED ADDITIONAL CAUTERY TO STOP THE BLEEDING. THE PATIENT WAS REPORTED TO BE DOING WELL AND HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL. THE TREATING SURGEON DOES NOT ATTRIBUTE THIS EVENT TO AQUABLATION. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.