BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELITE & USA DISPOSABLE ACTIVE CORD

    MDR report key: 2950307 · Received February 6, 2013

    Report

    Report Number
    2183680-2013-00009
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    December 19, 2012
    Report Date
    January 8, 2013
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    HIH
    PMA / PMN Number
    K890328
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFO 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 INFO BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    GYRUS ACMI WAS INFORMED THAT DURING AN ATTEMPTED OPERATIVE HYSTEROSCOPY PROCEDURE, ARCING OF THE HYSTEROSCOPE/CAUTERY OCCURRED AT THE BEGINNING OF THE PROCEDURE. THE PROCEDURE WAS ABANDONED AND THE SET UP WAS REPLACED TO PERFORM A DIAGNOSTIC HYSTEROSCOPY TO VISUALIZE THE INTERIOR OF THE VAGINAL VAULT. USER FACILITY CONFIRMED BURN ON THE FIBROID. (SEE MFR REPORT # 3006159227-2013-00001 FOR OTHER DEVICE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51318 ELITE & USA DISPOSABLE ACTIVE CORD DISPOSABLE ACTIVE CORD HIH GYRUS MEDICAL, INC. DAC 448133DE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK