BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALO PKS CUTTING FORCEPS

    MDR report key: 2110883 · Received May 20, 2011

    Report

    Report Number
    2183680-2011-00013
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 8, 2011
    Report Date
    May 20, 2011
    Manufacturer
    GYRUS MEDICAL INC.
    Product Code
    HIN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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 UPGRADE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    DURING A PROCEDURE WHILE USING THE HALO CUTTING FORCEPS DEVICE LAPAROSCOPICALLY TO CAUTERIZE TISSUE. THE DEVICE WORKED APPROPRIATELY WHEN IN CONTACT WITH THE PT TISSUE BUT ONCE IT WAS REMOVED FROM THE PT'S BODY CAVITY, THE TIPS STAYED ACTIVATED EVEN THOUGH THE BUTTON USED TO ACTIVATE THE DEVICE WAS NOT DEPRESSED. THE DEVICE WAS REMOVED IMMEDIATELY FROM THE FIELD AND REPLACED WITH AN ALTERNATE DEVICE WHICH COMPLETED THE CASE WITH NO FURTHER ISSUES OR COMPLICATIONS. NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALO PKS CUTTING FORCEPS CUTTING FORCEPS HIN GYRUS MEDICAL INC. HACF0533

    Patients

    Seq Age Sex Outcome Treatment
    1