BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP

    MDR report key: 2831029 · Received November 2, 2012

    Report

    Report Number
    1219930-2012-00880
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 4, 2012
    Manufacturer
    COVIDIEN, FORMERLY US SUR
    Product Code
    FZP
    PMA / PMN Number
    K100242
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP ASSISTED DISTAL GASTRECTOMY. ACCORDING TO THE REPORTER: DURING THE CASE, BLEEDING OCCURRED FROM THE SIDE OF 1ST CLIP WHICH WAS APPLIED ON THE RIGHT GASTROEPIPLOIC VEIN. THE SAME TROUBLE OCCURRED AFTER SECOND FIRING. USING ANOTHER DEVICE, THE PROCEDURE WAS COMPLETED. BLEEDING WAS LESS THAN 200CC. NO TISSUE DAMAGE. NO ADDITIONAL TISSUE LOSS. NOTHING FELL INTO CAVITY. A VIDEO WAS RECEIVED OF THE CASE AND THE VESSEL APPEARED TO BE TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP DISPOSABLE CLIP APPLIER FZP COVIDIEN, FORMERLY US SUR N2F0304X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other