BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELITE IGLESIAS BIPOLAR WORKING ELEMENT

    MDR report key: 3001408 · Received March 7, 2013

    Report

    Report Number
    1519132-2013-00005
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FDC
    PMA / PMN Number
    K021166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFORMATION FROM THE HOSPITAL HAVE BEEN UNSUCCESSFUL, AND THE DEVICE HAS NOT YET BEEN RETURNED FOR EVAL. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFORMATION BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GYRUS ACMI THA THE WORKING ELEMENT BROKE DURING A SURGICAL PROCEDURE. NO HARM TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98097 ELITE IGLESIAS BIPOLAR WORKING ELEMENT WORKING ELEMENT FDC GYRUS ACMI, INC. EIWE-PKFL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK