BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPAIR CORE SABER DRILL

    MDR report key: 1923849 · Received December 7, 2010

    Report

    Report Number
    1811755-2010-01928
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR INVESTIGATION. BASED ON THE INVESTIGATION DETAILS, THE ROTOR WAS DAMAGED. THE ROTOR WAS REPLACED AND THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS RUNNING ON ITS OWN. THERE WAS NO PT INVOLVEMENT AND NO ALLEGATION OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK