BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 7045209 · Received November 20, 2017

    Report

    Report Number
    1045834-2017-50002
    Event Type
    Malfunction
    Date Received
    November 20, 2017
    Report Date
    October 26, 2017
    Manufacturer
    THE ANSPACH EFFORT LLC
    Product Code
    HBC
    UDI-DI
    00845384002055
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND IT WAS DETERMINED THAT THE DEVICE PASSED ALL OPERATIONAL SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED. THEREFORE, THE REPORTED CONDITION WAS NOT CONFIRMED AND AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COCHLEAR IMPLANT PROCEDURE, IT WAS OBSERVED THAT THE MOTOR DEVICE WAS RUNNING HOT. IT WAS REPORTED THAT THE DEVICE WAS SUCCESSFULLY TESTED DURING PRE-SURGERY SET UP. IT WAS REPORTED THAT THERE WAS A TEN MINUTE DELAY IN THE SURGICAL PROCEDURE IN ORDER TO OBTAIN A SPARE DEVICE. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED SUCCESSFULLY; AND THAT THE PATIENT WAS NOT AFFECTED. IT WAS REPORTED THAT THE DEVICE WAS IN USE FOR ABOUT 40 MINUTES BEFORE THE ISSUE WAS OBSERVED. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824631 EMAX 2 PLUS MOTOR MOTOR, DRILL, ELECTRIC - HANDPIECE HBC THE ANSPACH EFFORT LLC EMAX2PLUS 00845384002055

    Patients

    Seq Age Sex Outcome Treatment
    1