BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL DRILL

    MDR report key: 1851027 · Received September 27, 2010

    Report

    Report Number
    1811755-2010-01249
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 13, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY THE MFR FOR INVESTIGATION. THE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE FILED IF THE INVESTIGATION DETAILS REQUIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE OVERHEATED DURING A ROUTINE MAINTENANCE VISIT. THERE WAS NO PT INVOLVEMENT. THERE IS NO REPORT OF ADVERSE CONSEQUENCE IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL DRILL EAR, NOSE, AND THROAT ELECTRIC OR PNEUMATIC SURGIC ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK