BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE IMPACT

    MDR report key: 1492277 · Received October 1, 2009

    Report

    Report Number
    1717344-2009-00483
    Event Type
    Injury
    Date Received
    October 1, 2009
    Date of Event
    August 13, 2009
    Report Date
    August 21, 2009
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF INITIAL REPORT: 10/02/2009. THE JAWS OF THE INCIDENT SAMPLE WERE LOCKED SHUT WHEN RECEIVED AND HAD TO BE PRIED OPEN. THE JAWS OPENED AND CLOSED NORMALLY. THE KNIFE DID NOT EXTEND OR RETRACT WHEN THE TRIGGER WAS ACTIVATED DUE TO TISSUE IN THE WEBBING. THE KNIFE WAS INSPECTED AND REVEALED THE WEBBING WAS NOT BENT. COVIDIEN LP (FORMERLY VALLEYLAB) PROVIDES AN ONLINE BULLETIN TO INFORM CUSTOMERS ON HOW TO AVOID TISSUE BUILDUP THAT CAN LEAD TO STICKING. THIS BULLETIN REITERATES INFO PROVIDED IN THE IFU WHICH STATES THAT IF THE JAWS ARE NOT CLEANED AS INSTRUCTED, ESCHAR CAN BUILD UP AND CAUSE THE JAWS TO STICK TO THE SEALED TISSUE. THIS CAN LEAD TO DIFFICULTY IN OPENING AND CLOSING THE DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON THE LAST SEALING ATTEMPT OF A LAPAROSCOPIC HYSTERECTOMY, THE INSTRUMENT DID NOT OPEN. THE DEVICE WAS PULLED OFF OF TISSUE WITH NO BLEEDING, BUT THE SURGERY CONVERTED TO OPEN AT THAT POINT AS THE SURGEON DID NOT WANT TO OPEN A NEW DEVICE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 163742

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other