BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER STICK M4

    MDR report key: 18140264 · Received November 15, 2023

    Report

    Report Number
    9611102-2023-00066
    Event Type
    Malfunction
    Date Received
    November 15, 2023
    Date of Event
    October 30, 2023
    Report Date
    November 15, 2023
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GEY
    UDI-DI
    04055207017982
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) OF AN ISSUE REGARDING A MOTOR HANDPIECE MAX. 6000RPM, PART ID: 8564.021, SN # (B)(6) . ACCORDING TO THE CUSTOMER, THE HANDPIECE LOST SUCTION NEAR THE END OF A HOLEP PROCEDURE. THE REPORTED ISSUE CAUSED A 30 MINUTE DELAY DURING THE PROCEDURE TO CHANGE DISPOSABLES OF THE SYSTEM. THE SCHEDULED PROCEDURE WAS COMPLETED. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981611 POWER STICK M4 MOTOR HANDPIECE MAX. 6000RPM GEY RICHARD WOLF GMBH 8564021 04055207017982

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown