BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO OSCILLATING SAW

    MDR report key: 2982895 · Received February 28, 2013

    Report

    Report Number
    0001811755-2013-00396
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, CORROSION WAS FOUND IN THE MOTOR, ROTOR AND ECCENTRIC GEAR. INCREASED FRICTION DUE TO CORROSION IS A PROBABLE CAUSE OF THE REPORTED OVERHEATING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE DEVICE OVERHEATED. A DELAY OF 15 MINUTES TO THE PROCEDURE WAS REPORTED, AND ADDITIONAL ANESTHESIA WAS ADMINISTERED. A BACKUP DEVICE WAS USED TO COMPLETE THE CASE. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86280 MICRO OSCILLATING SAW DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other