BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP

    MDR report key: 3131442 · Received May 10, 2013

    Report

    Report Number
    1219930-2013-00346
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    FZP
    PMA / PMN Number
    K071406
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: DURING THE PROCEDURE, WHILE TRYING TO CLIP, THE PT BLED, TRIED ANOTHER SPOT TO CLIP, PT BLED. NOTICED THE CLIP END WAS LOOSE, OPENED ANOTHER 5MM CLIP APPLIER AND WAS WORKING PROPERLY. THE CLIPS FELL INTO THE PT'S CAVITY BUT WERE RETRIEVED. THERE WAS EXCESSIVE BLEEDING FROM CYSTIC ARTERY. THE BLEEDING WAS REPORTED IN EXCESS OF 500CC BUT DID NOT REQUIRE A BLOOD TRANSFUSION. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209326 ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP DISPOSABLE CLIP APPLIER FZP COVIDIEN, FORMERLY US SURGICAL N3C0100X

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other