BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO OSCILLATING SAW

    MDR report key: 2950754 · Received February 8, 2013

    Report

    Report Number
    0001811755-2013-00210
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, CORROSION WAS DISCOVERED THROUGHOUT THE INTERNAL COMPONENTS OF THE DEVICE, INCLUDING THE MOTOR, WHICH IS A PROBABLE CAUSE OF THE REPORTED BIAS CURRENT ERROR. THE DEVICE HAS BEEN REPAIRED, BUT IT HAS NOT BEEN RETURNED TO THE USER FACILITY AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY, THE SAW CAUSED A BIAS CURRENT WARNING TO BE DISPLAYED ON THE CONSOLE, SIGNALING A CONDITION OCCURRED IN WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. 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
    53711 MICRO OSCILLATING SAW DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1