BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO RECIPROCATING SAW

    MDR report key: 2200990 · Received July 1, 2011

    Report

    Report Number
    1811755-2011-02347
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORROSION DAMAGE WAS NOTED WITHIN THE INTERNAL COMPONENTS OF THE DEVICE.

    Description of Event or Problem · 1

    THE MICRO RECIPROCATING SAW WAS SENT IN FOR EVAL BECAUSE IT WAS RUNNING ON ITS OWN. THE EVENT OCCURRED DURING A ROUTINE MAINTENANCE VISIT; NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO RECIPROCATING SAW ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK