BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PKS HALO CUTTING FORCEPS

    MDR report key: 3102833 · Received May 2, 2013

    Report

    Report Number
    2183680-2013-00021
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    April 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    GEI
    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 UPGRADE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    GYRUS (B)(4) WAS INFORMED THAT DURING A LAP HYSTERECTOMY PROCEDURE A BLACK CIRCULAR PIECE OF MATERIAL FELL INTO THE ABDOMINAL CAVITY OF THE PT. THE PIECE WAS RETRIEVED AND INSPECTED, AND IT WASN'T IMMEDIATELY OBVIOUS THAT THE PIECE CAME FROM THE HALO. THE SURGEON CONTINUED THE PROCEDURE BUT THE HALO DEVICE WOULD NO LONGER COAG. A NEW HALO CUTTING FORCEPS DEVICE WAS OPENED AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193016 PKS HALO CUTTING FORCEPS PKS HALO CUTTING FORCEPS GEI GYRUS MEDICAL, INC. HACF0533 JF502923

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK