BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI-CLIP

    MDR report key: 2875029 · Received November 21, 2012

    Report

    Report Number
    2875029
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 6, 2012
    Report Date
    November 21, 2012
    Manufacturer
    COOK MEDICAL, INC.
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TECH ATTEMPTED TO OPEN THE CLIP DURING THE PROCEDURE, SEVERAL ATTEMPTS WERE MADE, BUT IT FAILED TO OPEN. CLIP WAS REMOVED FROM SCOPE AND ANOTHER CLIP WAS USED WITHOUT PROBLEM. CLIP WAS GIVEN TO NURSE EDUCATOR.LARGE DUODENAL ULCER IN THE BULB WITH 2 VISIBLE VESSELS, NON-BLEEDING, TREATED WITH HEATER PROBE, EPINEPHRINE, AND HEMOCLIPS. AT ONE POINT, PHYSICIAN DID ATTEMPT TO PLACE THE FAILED HEMOCLIP ON THE SMALLER VESSEL AS MIDWAY THROUGH TREATMENT WITH HEATER PROBE, THERE WAS A SMALL AMOUNT OF OOZING, WHICH OCCURRED. THE HEMOCLIP PLACEMENT WAS UNSUCCESSFUL. NO ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRI-CLIP CLIP, IMPLANTABLE, HEMOSTASIS FZP COOK MEDICAL, INC. * W3188858

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR