BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE UNIVERSAL DRIVER

    MDR report key: 1924691 · Received December 9, 2010

    Report

    Report Number
    1811755-2010-01985
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 22, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRIVER WAS RECEIVED AT THE MFR FOR TESTING. AN EVAL WILL BE CONDUCTED, AND A FOLLOW-UP REPORT WILL BE SUBMITTED IF THE RESULTS OF THE QUALITY INVESTIGATION REQUIRE ONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRIVER WAS SMOKING DURING A SURGICAL PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY USING A BACK-UP DEVICE. THE PT WAS NOT AFFECTED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE UNIVERSAL DRIVER SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTAC HBE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK