BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 11721158 · Received April 23, 2021

    Report

    Report Number
    3012977056-2021-00024
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    March 25, 2021
    Report Date
    May 28, 2021
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE AQUABEAM ROBOTIC SYSTEM'S LOG FILE WAS REVIEWED, WHICH CONFIRMED NO MALFUNCTIONS DURING THE AQUABLATION PROCEDURE. THE REVIEW OF THE LOG FILE INDICATED THAT THE SYSTEM FUNCTIONED AS DESIGNED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR AB2000-B REV E/LOT NUMBER: 20C00863 WAS PERFORMED, WHICH CONFIRMED THAT THERE WERE NO NONCONFORMANCES, 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. A REVIEW FOR SIMILAR COMPLAINTS UNDER AB2000-B REV E/LOT NUMBER: 20C00863 CONFIRMED NO OTHER SIMILAR EVENTS. A REVIEW OF SIMILAR COMPLAINTS ACROSS ALL OTHER SYSTEMS CONFIRMED A TOTAL OF 19 SIMILAR EVENTS REPORTED TO PROCEPT BIOROBOTICS. THE AQUABEAM ROBOTIC SYSTEM INSTRUCTIONS FOR USE, IFU0101-00 REV. E, STATES: 4.3 WARNINGS: PROCEDURE: AS WITH ANY SURGICAL UROLOGIC PROCEDURE, POTENTIAL PERIOPERATIVE RISKS OF THE AQUABLATION PROCEDURE INCLUDE: BLEEDING. 8.32 STERILE: A. AFTER THE AQUABEAM HANDPIECE REMOVAL, FOLLOW THE STANDARD CLOT EVACUATION PROCEDURE TO REMOVE CLOTS AND TISSUE WITH A CYSTOSCOPIC SHEATH BY USING AN ELLIK BLADDER EVACUATOR OR TOOMEY SYRINGE. B. USE ONE OF THE FOLLOWING METHODS TO ACHIEVE HEMOSTASIS: CAUTERY FOLLOWED BY FOLEY BALLOON CATHETER INSERTION. UNDER SPINAL ANESTHESIA, INSERT A BALLOON CATHETER IN THE BLADDER WITH BLADDER NECK TRACTION THEN FILL THE BLADDER WITH STERILE SALINE AND MAINTAIN FOR APPROXIMATELY 30-60 MINUTES BEFORE STARTING CBI (CONTINUOUS BLADDER IRRIGATION) BALLOON CATHETER IN BLADDER WITH BLADDER NECK TRACTION BALLOON CATHETER IN PROSTATIC FOSSA: INFLATE BALLOON WITH 5CC IN THE BLADDER UNDER TRUS GUIDANCE RETRACT BALLOON INTO PROSTATIC FOSSA INFLATE BALLOON TO 30-50% OF INITIAL PROSTATE VOLUME APPLY MILD TRACTION ON THE CATHETER TO HOLD THE BALLOON CATHETER IN PLACE BALLOON CATHETER IN BLADDER, NO TRACTION C. START CBI PER HOSPITAL PROTOCOL. THE INFORMATION REPORTED INDICATED THAT THE BLOOD TRANSFUSION WAS LIKELY NOT NECESSARY BASED ON THE HGB LEVELS OBSERVED PRE-AQUABLATION PROCEDURE AND POST-AQUABLATION PROCEDURE. ADDITIONALLY, THE PATIENT'S RETURN TO THE OPERATING ROOM FOR CLOT EVACUATION WAS DUE TO THE CONTINUOUS BLADDER IRRIGATION (CBI) RUNNING DRY. THE DEVICE INSTRUCTIONS FOR USE, IFU0101-00 REV E, AQUABEAM ROBOTIC SYSTEM, UNDER SECTION 8.31 CONTAINS ADEQUATE INSTRUCTIONS REGARDING CBI POST AQUABLATION THERAPY. BLEEDING IS A POTENTIAL RISK OF THE AQUABLATION PROCEDURE. BASED ON THE INFORMATION RECEIVED, PLUS REVIEW OF THE LOG FILE, DHR AND IFU, 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.

    Additional Manufacturer Narrative · 1

    ROOT CAUSE OF REPORTED EVENT HAS NOT YET BEEN ESTABLISHED. INVESTIGATION BY MANUFACTURER IS CURRENTLY INPROCESS. 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 · 1

    A MALE PATIENT UNDERWENT AN AQUABLATION PROCEDURE FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT POST-AQUABLATION PROCEDURE THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM DUE TO CLOT RETENTION (PER MANUFACTURER'S INSTRUCTIONS FOR USE, BLEEDING IS A POTENTIAL PERIOPERATIVE RISK OF THE AQUABLATION PROCEDURE). IT WAS DETERMINED THAT THE CONTINUOUS BLADDER IRRIGATION HAD RUN DRIED, AND CLOTS WERE UNABLE TO BE REMOVED WITH IRRIGATION; THEREFORE, THE PATIENT WAS TAKEN BACK TO THE OR FOR CLOT EVACUATION. IN ADDITION, THE PATIENT RECEIVED TWO (2) UNITS OF PACKED RED BLOOD CELLS (PRBCS) OVERNIGHT POST-AQUABLATION PROCEDURE. THERE WERE NO ADVERSE HEALTH CONSEQUENCES REPORTED WITH THE PATIENT DUE TO THIS EVENT. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616017 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION AB2000 B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention