BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULATING HOOK WITH MONOPOLAR CAUTERY

    MDR report key: 2001713 · Received February 22, 2011

    Report

    Report Number
    1219930-2011-00139
    Event Type
    Injury
    Date Received
    February 22, 2011
    Date of Event
    January 14, 2011
    Report Date
    February 1, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GEI
    PMA / PMN Number
    K091969
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: THE INSERTION WAS DONE FROM THE BELLY AREA. A KALOT TRIANGLE WAS PUT ASIDE BY DOING NECESSARY DISSECTIONS DURING THE INSUFFLATIONS. THE CYSTIC CHANNEL AND "ARTIER" WERE CLIPPED AND SEPARATED, THROUGH THE GALLBLADDER AND THE LIVER BED. THE DISSECTION WAS COMPLETED BY THE DEVICE. APPROX, 0.5 CM GALLBLADDER "PERITONEA" WAS ON THE "FONDUES" AREA. WHILE THE SPECIMEN WAS TAKEN FROM THIS AREA, THE EDGE OF THE DEVICE CAUGHT FIRE. ALL THE HAND GADGETS WERE TAKEN OUT WITH THE PORT. A DARK SMOKE AND FIRE WERE SEEN FROM THE ABDOMINAL CAVITY. AN IMMEDIATE LAPAROTOMY WAS DONE. NO PATHOLOGY MACROSCOPICALLY WERE NOTED INSIDE THE ABDOMINAL ORGANS. A 10 CM BURN ON THE UNDER PART OF THE SILS PORT WAS OBSERVED. THE BURN WAS ALSO ON THE TISSUE. SURGICAL TIME WAS EXTENDED DUE TO THE SHIFT FROM LAPAROSCOPY TO AN OPEN PROCEDURE. IN ADDITION TO THIS, THE ORGANS OF THE PT WERE CHECKED. THERE WAS NO EXTENSION OF THE INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICULATING HOOK WITH MONOPOLAR CAUTERY DISPOSABLE SURGICAL DEVICE GEI UNITED STATES SURGICAL N0C0911U

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R| S