BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 3001372 · Received March 7, 2013

    Report

    Report Number
    1717344-2013-00175
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 14, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT CLEAR INSULATION ON THE DEVICE ROLLED BACK ON ITSELF DURING A LAPAROSCOPIC RIGHT COLECTOMY. IT WAS ALSO NOTED THAT THERE WAS A BURN TO THE PT'S BOWEL. THE CAUSE OF THE BURN IS NOT KNOWN BUT THE SURGEON BELIEVES THAT IT WAS RELATED TO THE CLEAR INSULATION ROLLING UP ON ITSELF. IT IS ALSO UNK IF THE BURN HAPPENED BEFORE OR AFTER THE SURGEON NOTICED THE INSULATION HAD ROLLED UP ON ITSELF. THE SURGEON BELIEVES THE BURN TOOK PLACE WHILE THE DEVICE WAS BEING ACTIVATED IN MONOPOLAR AND IN AN AREA OF THE BOWEL THAT WAS GOING TO BE REMOVED. THE SURGEON REMOVED AN EXTRA 9CM OF BOWEL AND NOTED THAT THERE WOULD BE NO PHYSIOLOGICAL DAMAGE TO THE PT. THE CASE WAS EXTENDED FOR MORE THAN 30 MINUTES AS A RESULT. TROCARS MANUFACTURED BY ETHICON WERE IN USE, BUT IT IS UNK WHAT SPECIFIC TROCARS WERE USED. THE DEVICE WAS RETURNED WITH THE CLEAR INSULATION MISSING. ADDITIONAL QUESTIONS IN REGARD TO THE MISSING INSULATION HAVE ALSO BEEN ASKED. THE PT CONDITION HAS BEEN REPORTED AS BEING OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97714 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 240605X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ETHICON TROCAR: LOT NUMBER AND PRODUCT ID ARE UNK