BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO DRILL

    MDR report key: 3140646 · Received May 31, 2013

    Report

    Report Number
    0001811755-2013-01269
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS CONFIRMED THE ALLEGED BIAS CURENT ERROR WAS DUE TO CORRODED ROTOR AND MOTOR CAUSING NO POWER TO DRILL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MICRO DRILL DISPLAYED A BIAS CURRENT ERROR DURING TESTING BY THE END USERS SERVICE DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240699 MICRO DRILL DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1