BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 ASEPTIC HOUSING ASSY

    MDR report key: 4213400 · Received October 30, 2014

    Report

    Report Number
    0001811755-2014-03850
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 3, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT, THE DEVICE IS MISSING THE RUBBER GASKET, WAS CONFIRMED. THE COVER SEAL CAN BREAK OR DEGRADE DUE TO FATIGUE OR IMPROPER STERILIZATION INCLUDING EXPOSURE TO HIGH PH CLEANERS, EXPOSURE TO CLEANING SOLVENTS, OR FROM THE AUTOCLAVE. DEVICE WAS PLACED IN PARTS RETENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING ROUTINE MAINTENANCE CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY THAT THE RUBBER SEAL IS MISSING FORM THE LID OF THE HOUSING WHICH CAN CAUSE HOUSING TO NOT CLOSE PROPERLY. NO ASSOCIATED PROCEDURE, NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695111 SYSTEM 6 ASEPTIC HOUSING ASSY INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO 14016

    Patients

    Seq Age Sex Outcome Treatment
    1