BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUTTING LOOP

    MDR report key: 2950217 · Received February 6, 2013

    Report

    Report Number
    3006159227-2013-00001
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    December 19, 2012
    Report Date
    January 8, 2013
    Manufacturer
    GYRUS ACMI, 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 (B)(4) WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    GYRUS (B)(4) 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 NUMBER: 2183680-2013-00009 FOR OTHER DEVICE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50440 CUTTING LOOP CUTTING LOOP HIH GYRUS ACMI, INC. MLE-24-012 403267AE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK