BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 15075751 · Received July 21, 2022

    Report

    Report Number
    3012977056-2022-00092
    Event Type
    Malfunction
    Date Received
    July 21, 2022
    Date of Event
    June 21, 2022
    Report Date
    March 17, 2023
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS CURRENTLY IN PROCESS BY MANUFACTURER, NO ROOT CAUSE HAS YET BEEN ESTABLISHED. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 0

    H.10 ADDITIONAL MANUFACTURER NARRATIVE: TO DATE, THE AQUABEAM SCOPE HAS NOT BEEN MADE AVAILABLE TO PROCEPT BIOROBOTICS CORPORATION FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR AQUABEAM ROBOTIC SYSTEM/SERIAL NUMBER: (B)(6) AND THE AQUABEAM SCOPE / LOT NUMBER: 72109/S0029 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 AND ITS ASSOCIATED COMPONENT MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. A 12-MONTH SIMILAR COMPLAINT REVIEW IDENTIFIED 20 OTHER SIMILAR EVENTS HAVE BEEN REPORTED TO PROCEPT. AQUABEAM ROBOTIC SYSTEM USER MANUAL, UM0101-00 REV. F, WAS REVIEWED AND STATES THE FOLLOWING: 11.2.5 STERILE: AQUABEAM HANDPIECE AND AQUABEAM SCOPE SETUP HOLD THE DISTAL END OF THE SCOPE TUBE TIP APPROXIMATELY 1 INCH (2.54 CM) FROM THE FULLY PROXIMAL POSITION AND CONTINUE ADVANCING THE AQUABEAM SCOPE FORWARD UNTIL IT IS PROPERLY ENGAGED WITH THE AQUABEAM HANDPIECE AND THEN ROTATE THE PROXIMAL KEY ALIGNMENT ADAPTER SO THAT THE DIMPLE ON THE PROXIMAL KEY ALIGNMENT ADAPTER IS FACING UP. AN AUDIBLE CLICK SHOULD BE HEARD WHEN THE AQUABEAM SCOPE IS SECURELY ENGAGED WITH THE AQUABEAM HANDPIECE. NOTE: DO NOT USE EXCESSIVE FORCE TO ADVANCE THE AQUABEAM SCOPE. IF RESISTANCE IS FELT,GENTLY ROTATE THE AQUABEAM SCOPE CLOCKWISE AND COUNTERCLOCKWISE WHILE SIMULTANEOUSLY APPLYING FORWARD PRESSURE. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 0

    THE AQUABEAM SCOPE WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION WAS ABLE TO CONFIRM THE REPORTED EVENT AS THE SCOPE WAS OBSERVED TO BE SNAPPED INTO TWO PIECES WITH MULTIPLE KINKS AND BREAKAGES ALONG THE SEMI-FLEXIBLE HYPOTUBE. THE ROOT CAUSE IS UNDETERMINABLE, HOWEVER, IT IS LIKELY THAT IT WAS CAUSED BY EXCESSIVE PRESSURE BEING APPLIED ON THE SCOPE. THE CURRENT USER MANUAL EXPLICITLY MENTIONS HOW TO REDUCE SCOPE BREAKAGES - "DO NOT USE EXCESSIVE FORCE TO ADVANCE THE AQUABEAM SCOPE. IF RESISTANCE IS FELT, GENTLY ROTATE THE AQUABEAM SCOPE CLOCKWISE AND COUNTERCLOCKWISE WHILE SIMULTANEOUSLY APPLYING FORWARD PRESSURE AND 11.2.21 AQUABEAM ROBOTIC SYSTEM DISASSEMBLY - HOLDING THE AQUABEAM HANDPIECE SCOPE TUBE TIP, ROTATE THE SCOPE PROXIMAL KEY ADAPTOR ABOUT 30 DEGREES CLOCKWISE AND COUNTERCLOCKWISE WHILE PULLING THE AQUABEAM SCOPE OUT OF THE AQUABEAM HANDPIECE. 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 · 0

    A MALE PATIENT UNDERWENT AN AQUABLATION PROCEDURE FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT DURING THE AQUABLATION PROCEDURE THE AQUABEAM THE SCOPE BROKE WHILE BEING SETUP. THE SCOPE WAS REPLACED WITH A NEW UNIT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE REPORTED EVENT CAUSED A SURGICAL PROCEDURAL DELAY OF OVER 20 MINUTES. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THE PROCEDURAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263068 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION AB2000 B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1 Male