BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3111946 · Received May 14, 2013

    Report

    Report Number
    1045834-2013-02127
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 15, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MOTOR DEVICE WAS RECEIVED FOR EVALUATION. THE MOTOR DEVICE WAS TESTED AND MET TEMPERATURE SPECIFICATIONS. THE REPORTED CONDITION COULD NOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT DURING A COCHLEAR IMPLANT SURGERY THE MOTOR DEVICE AND THE ATTACHMENT DEVICE ¿HEATED UP.¿ THERE WAS NO DELAY REPORTED IN SURGERY. THERE WAS A SPARE IDENTICAL MOTOR DEVICE AVAILABLE FOR USE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WERE NO INJURIES OR MEDICAL INTERVENTION REQUIRED. THOUGH REQUESTED, PATIENT INFORMATION WOULD NOT BE DISCLOSED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211919 EMAX 2 PLUS MOTOR MOTOR, DRILL, ELECTRIC-HANDPIECE HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1