BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3080952 · Received April 24, 2013

    Report

    Report Number
    1045834-2013-02036
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    December 1, 2012
    Report Date
    March 26, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED BY ANSPACH. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT 2 OF 3. REPORT RECEIVED FROM (B)(6) STATING THAT DURING A SURGICAL PROCEDURE, "SMOKE" WAS COMING FROM THE JOINT BETWEEN THE DEVICE AND THE CSR60 (PERFORATOR DRIVER ATTACHMENT). THE REPORTER ALSO STATED THAT THE "BAR FELL OFF" THE DEVICE. IT WAS UNKNOWN TO THE REPORTER WHETHER OR NOT THERE WAS A DELAY IN THE SURGICAL PROCEDURE. THERE WERE THREE SPARE DEVICE AVAILABLE FOR USE. IT WAS UNKNOWN IF MEDICAL INTERVENTION WAS REQUIRED. THE PT INFORMATION WAS UNKNOWN TO THE REPORTER. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177916 EMAX 2 PLUS MOTOR HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1