BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 3

    MDR report key: 4213401 · Received October 30, 2014

    Report

    Report Number
    0001811755-2014-03846
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    September 15, 2014
    Report Date
    October 3, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LH
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE DEVICE HAD ALLEGEDLY OVERHEATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN ALTERNATIVE DEVICE. NO CLINICALLY SIGNIFICANT DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695774 CORDLESS DRIVER 3 ARTHROSCOPE HRX STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1