BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP

    MDR report key: 2190463 · Received July 29, 2011

    Report

    Report Number
    1219930-2011-00624
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    May 16, 2011
    Report Date
    July 14, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    FZP
    PMA / PMN Number
    K954435
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 SURGERY, IT APPEARED THAT THE CLIPS DEPLOYED CORRECTLY. SEVERAL HOURS LATER, POST OPERATIVE HEMORRHAGE OCCURRED. LAPAROTOMY PERFORMED AND BLOOD REMOVED. IT WAS FOUND THAT THE CLIP HAD COME OFF THE CYSTIC ARTERY AND THE BLEED WAS FROM THE CYSTIC ARTERY STUMP. THE ARTERY WAS RE-CLIPPED. THE PATIENT REQUIRED 11 UNITS OF BLOOD AND 6 WEEKS OF RE-COOPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP DISPOSABLE CLIP APPLIER FZP UNITED STATES SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R