BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAPR-CLIP 12MM LPW

    MDR report key: 2617975 · Received June 11, 2012

    Report

    Report Number
    1219930-2012-00487
    Event Type
    Injury
    Date Received
    June 11, 2012
    Date of Event
    May 29, 2012
    Report Date
    May 31, 2012
    Manufacturer
    COVIDIEN, FORMERLY US SUR
    Product Code
    GCJ
    PMA / PMN Number
    K925602
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT SENT TO FDA ON (B)(4) 2012.

    Description of Event or Problem · 1

    PROCEDURE TYPE: LADG - LAP ASSISTED DISTAL GASTRECTOMY. ACCORDING TO THE REPORTER: 8MM CLIPS WERE APPLIED ON RIGHT GASTRIC ARTERY, RIGHT GASTRIC VEIN AND ARTERY UNDER PYLORUS. AT THE 4TH FIRING WITH 12MM, IT WAS CONFIRMED WITH ENDOSCOPE THE CLIP WAS CLOSED PROPERLY ON LEFT GASTRIC ARTERY, BUT THE CARTRIDGE ITSELF FELL INTO CAVITY WHEN THE DEVICE WAS REMOVED FROM VESSEL. THE SURGEON CUT THE VESSEL FIRST AND WAS ABOUT TO RETRIEVE THE FALLEN CARTRIDGE, AND CLIP ON VESSEL CAME OFF AND BLEEDING OCCURRED. PROCEDURE WAS CONVERTED TO OPEN AND COMPLETED WITH FURTHER PROBLEM. THE PATIENT'S CONDITION IS STABLE. BLEEDING WAS LESS THAN 200CC. THERE WAS NO TISSUE DAMAGE. THE FALLEN CARTRIDGE WAS RETRIEVE. OPERATING ROOM TIME WAS EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAPR-CLIP 12MM LPW DISPOSABLE CLIP APPLIER GCJ COVIDIEN, FORMERLY US SUR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R