BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 2 HANDPIECE

    MDR report key: 2922387 · Received January 18, 2013

    Report

    Report Number
    0001811755-2013-00021
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 2, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, CORROSION WAS FOUND THROUGHOUT THE INTERNAL COMPONENTS OF THE DEVICE, WHICH WAS IDENTIFIED AS A PROBABLE CAUSE OF THE LEAKING OF BROWN LIQUID DURING CLEANING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CLEANING AT THE USER FACILITY, THE DEVICE WAS LEAKING BROWN FLUID. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27696 CORDLESS DRIVER 2 HANDPIECE ARTHROSCOPE HRX STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1