BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE SUMEX DRILL

    MDR report key: 3013425 · Received March 20, 2013

    Report

    Report Number
    0001811755-2013-00567
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON DISASSEMBLY FOR VISUAL INSPECTION AN ISSUE WITH THE MOTOR CIRCUIT WAS FOUND.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WHEN THE DEVICE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CORE SUMEX DRILL WAS SENT FOR EVALUATION AND BIAS CURRENT ERROR WAS EXPERIENCED. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    THE CORE SUMEX DRILL WAS SENT FOR EVALUATION AND BIAS CURRENT ERROR WAS EXPERIENCED. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116227 CORE SUMEX DRILL EAR, NOSE, AND THROAT ELECTRIC OR PNEUMATIC SURGICAL DRILL ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1