BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SNGL LAPRO-CLIP 12MM

    MDR report key: 3940871 · Received July 8, 2014

    Report

    Report Number
    1219930-2014-00507
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 17, 2014
    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).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: DURING PROCEDURE IT COULD FIRE SUCCESSFULLY ON THE BILE DUCT AND THE CASE WAS COMPLETED WITH NO PROBLEM. HOWEVER 6 DAYS AFTER THE PROCEDURE THE BILE SPILLAGE WAS CONFIRMED BY ENDOSCOPIC EXAMINATION: THE DOCTOR OBSERVED THE CONDITIONS THAT SOME CLIPS CAME OFF THE TISSUE AND THOSE CLIPS WERE ABSORBED. THEN THE ADDITIONAL ENDOSCOPIC SURGERY WAS REQUIRED. THE PART WHERE THE CLIPS CAME OFF WERE RECOVERED BY CLIPPING AGAIN. THE SURGEON CONSIDERS THIS EVENT MIGHT OCCUR BY THE CAUSE RELATED TO THE CONDITIONS IN THE PATIENT. OPERATING TIME NOT EXTENDED. ADDITIONAL TISSUE RESECTION: NO. TISSUE DAMAGE: YES. NOTHING FELL INTO THE CAVITY. NO BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395571 SNGL LAPRO-CLIP 12MM DISPOSABLE CLIP APPLIER GCJ COVIDIEN, FORMERLY US SUR N4D1136X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention