BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 11325255 · Received February 12, 2021

    Report

    Report Number
    3012977056-2021-00008
    Event Type
    Malfunction
    Date Received
    February 12, 2021
    Date of Event
    February 3, 2021
    Report Date
    May 24, 2021
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3. DEVICE EVALUATION BY MANUFACTURER: A VISUAL INSPECTION OF THE RETURNED AQUABEAM SCOPE CONFIRMED NO VISIBLE DAMAGE; THE PRODUCT WAS INTACT AND DID NOT ALIGN WITH THE INITIAL INFORMATION PROVIDED TO PROCEPT BIOROBOTICS WHERE THE SCOPE JAMMED AND SNAPPED. THE CUSTOMER WAS CONTACTED TO DETERMINE WHETHER THE CORRECT PRODUCT HAD BEEN RETURNED, BUT WAS UNABLE TO LOCATE THE DEFECTIVE SCOPE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE AQUABEAM SCOPE AND AQUABEAM ROBOTIC SYSTEM, 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 DEVICE MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. A REVIEW FOR SIMILAR COMPLAINTS CONFIRMED THAT THERE ARE NO OTHER SIMILAR EVENTS THAT HAVE BEEN REPORTED TO PROCEPT BIOROBOTICS. THE AQUABEAM ROBOTIC SYSTEM'S USER MANUAL, UM0101-00 REV. E, WAS REVIEWED AND STATES THE FOLLOWING: 11.2.5 STERILE: AQUABEAM HANDPIECE AND AQUABEAM SCOPE SETUP VERIFY THE AQUABEAM SCOPE VISUALIZATION VIA THE CAMERA SOURCE PORT. NOTE: OBTAIN A NEW AQUABEAM SCOPE IF PROPER VISUALIZATION CANNOT BE VERIFIED WHILE SUPPORTING THE AQUABEAM HANDPIECE, GENTLY GRIP THE MIDDLE OF THE SEMI-RIGID SECTION OF THE AQUABEAM SCOPE AND PARTIALLY INSERT THROUGH THE CLEAR RUBBER SEAL ON THE BOTTOM OF THE AQUABEAM HANDPIECE. HOLD THE DISTAL END OF THE SCOPE TUBE TIP APPROXIMATELY 1 INCH (2.54CM) 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. CONFIRM THE AQUABEAM SCOPE IS FULLY ENGAGED BY ADVANCING AND RETRACTING THE SCOPE PROXIMAL KEY AND OBSERVING THE SCOPE TUBE TIP MOVING IN CONCERT WITH THE AQUABEAM SCOPE. WITH THE PROXIMAL KEY FULLY RETRACTED, ALIGN THE SCOPE CARRIAGE OVER THE PROXIMAL KEY ADAPTER. ATTACH TO THE AQUABEAM HANDPIECE BY PUSHING THE SCOPE CARRIAGE FORWARD TO ENGAGE WITH THE CARRIAGE TRACK. USING THE KNOBS ON THE CARRIAGE, ADVANCE THE AQUABEAM SCOPE FORWARDS (DISTAL) AND BACKWARDS (PROXIMAL) TO ENSURE THAT THE AQUABEAM SCOPE IS FULLY ENGAGED WITH THE AQUABEAM HANDPIECE. THE SCOPE TUBE TIP SHOULD MOVE FORWARDS AND BACKWARDS IN CONCERT WITH THE MOVEMENT OF THE AQUABEAM SCOPE. A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. VISUAL INSPECTION OF THE RETURNED AQUABEAM SCOPE FOUND NO VISIBLE DAMAGE. THROUGH ADDITIONAL INFORMATION REQUESTED IT WAS CONFIRMED THAT THE CUSTOMER WAS UNABLE TO FIND THE DEFECTIVE SCOPE. THE ROOT CAUSE OF THE REPORTED EVENT IS UNDETERMINABLE AS THE WRONG SCOPE WAS RETURNED. 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.

    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 DURING THE AQUABLATION PROCEDURE THE AQUABEAM SCOPE BECAME JAMMED INSIDE THE AQUABEAM HANDPIECE, CAUSING A PROCEDURAL DELAY OF OVER 20 MINUTES. THE SCOPE WAS REPLACED AND THE AQUABLATION PROCEDURE CONTINUED TO COMPLETION. THERE WERE NO ADVERSE HEALTH CONSEQUENCES WITH THE PATIENT BECAUSE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221070 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION AB2000 B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1