BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 11652482 · Received April 12, 2021

    Report

    Report Number
    3012977056-2021-00018
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    March 27, 2021
    Report Date
    December 16, 2021
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3 DEVICE EVALUATION BY MANUFACTURER: THE AQUABEAM SCOPE AND ASSOCIATED AQUABEAM HANDPIECE WERE RETURNED FOR INVESTIGATION. THE REPORTED EVENT WAS ABLE TO BE REPRODUCED BY MANUALLY ATTEMPTING TO TRANSLATE THE SCOPE TIP. THE HANDPIECE AND SCOPE WERE STUCK TOGETHER. THERE WAS RUST ON THE SEMI-FLEX HYPOTUBE ABOUT 4.34" IN LENGTH FROM THE PROXIMAL KEY ON THE RETURNED SCOPE. DURING THE INVESTIGATION THE SCOPE WAS REMOVED FROM THE HANDPIECE AND UPON REINSERTING THE SCOPE INTO THE HANDPIECE, IT WAS NOTED THAT THERE WAS DIFFICULTY MOVING THE SCOPE. THERE WERE CRACKS WITH THE MANIFOLD ADHESIVE AND NO GALLING ON THE HANDPIECE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED, WHICH CONFIRMED THAT THERE WERE NO NONCONFORMANCES GENERATED DURING THE MANUFACTURING PROCESS OF THIS SYSTEM AND/OR SCOPE ASSOCIATED TO THIS EVENT. THE REVIEW INDICATED THAT THE SYSTEM AND/OR SCOPE MET ALL REQUIRED SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A REVIEW FOR SIMILAR COMPLAINTS CONFIRMED A TOTAL OF FIVE (5) SIMILIAR EVENTS REPORTED ON THIS ISSUE. THE AQUABEAM ROBOTIC SYSTEM'S INSTRUCTIONS FOR USE (IFU), IFU0104-00, REV. B, STATES THE FOLLOWING: 5.1. PRECAUTIONS: GENERAL: IF EXCESSIVE RESISTANCE IS ENCOUNTERED DURING AQUABEAM SCOPE POSITIONING, REPOSITION THE AQUABEAM HANDPIECE TO MINIMIZE TENTING THE PROSTATE IN ORDER TO REDUCE THE CHANCE OF DAMAGING THE AQUABEAM SCOPE. THE AQUABEAM ROBOTIC SYSTEM'S USER MANUAL, UM0104-00 REV. F, STATES THE FOLLOWING: 11.2.5 STERILE: AQUABEAMHANDPIECE AND AQUABEAM SCOPE SETUP STATES: RETRACT THE SCOPE TUBE TIP ON THE AQUABEAM HANDPIECE TO 1 INCH (2.54 CM) IN FRONT OF ITS FULLY PROXIMAL POSITION. 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 (2.54 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. 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 THEAQUABEAM SCOPE. THE ROOT CAUSE OF THE SCOPE TIP TRANSLATION ISSUE WAS DETERMINED TO BE DUE TO A BENT TELESCOPING TUBE FROM A COMPRESSIVE LOAD DUE TO TENTING THE PROSTATE DURING THE PROCEDURE AS EVIDENCED BY CRACKS ON THE MANIFOLD ADHESIVE. THE AQUABEAM ROBOTIC SYSTEM'S INSTRUCTIONS FOR USE AND USER MANUAL CONTAIN ADEQUATE INFORMATION REGARDING THIS ISSUE. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 0

    FOR CORRECTED DATA REFER TO INFORMATION BELOW. H.3 DEVICE EVALUATION BY MANUFACTURER: A REVIEW FOR SIMILAR COMPLAINTS CONFIRMED NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED TO PROCEPT. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION HAS NOT YET BEGUN BY THE MANUFACTURER.

    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 TREATING PHYSICIAN ENCOUNTERED DIFFICULTY MANEUVERING THE AQUABEAM SCOPE INSIDE THE AQUABEAM HANDPIECE, WHICH ULTIMATELY LED TO REPLACEMENT OF BOTH COMPONENTS AND SUCCESSFUL COMPLETION OF PROCEDURE. THE REPORTED EVENT CAUSED A SURGICAL PROCEDURAL DELAY OF OVER 20 MINUTES. THERE WERE NO ADVERSE HEALTH CONSEQUENCES WITH THE PATIENT BECAUSE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548498 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION AB2000 B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1 Male