BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE IMPACT

    MDR report key: 1291590 · Received January 13, 2009

    Report

    Report Number
    1717344-2009-00003
    Event Type
    Injury
    Date Received
    January 13, 2009
    Date of Event
    December 5, 2008
    Report Date
    December 15, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE JAWS OF THE INCIDENT DEVICE WERE STUCK CLOSED WHEN THE SAMPLE WAS RECEIVED. THERE WAS TISSUE BETWEEN THE JAWS AND IN THE KNIFE TRACK. TISSUE IN THE KNIFE TRACK KEPT THE KNIFE FROM FULLY RETRACTING AND CAUSING THE JAWS NOT TO OPEN. THE KNIFE WAS NOT PROTRUDING FROM THE JAWS OF THE DEVICE. THE KNIFE WAS INSPECTED AND THE WEBBING WAS NOT BENT. COVIDIEN LP (FORMERLY VALLEYLAB) PROVIDES AN ONLINE BULLETIN TO INFORM CUSTOMERS HOW TO AVOID TISSUE BUILDUP THAT CAN LEAD TO STICKING. THIS BULLETIN REITERATES INFORMATION 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. TURNING THE ROTATION WHEEL WHILE THE HANDLE IS FULLY CLOSED CAN ALSO CAUSE THE JAWS TO LOCK SHUT. THE IFU STATES, "DO NOT TURN THE ROTATION WHEEL WHEN THE HANDLE IS LATCHED. PRODUCT DAMAGE MAY OCCUR. THE JAWS MAY LOCK IN THE CLOSED POSITION."

    Description of Event or Problem · 1

    THE REPORT STATED THAT DURING A PROSTATECTOMY, WHILE WORKING DEEP IN THE PELVIS, THE JAWS OF THE INSTRUMENT LOCKED ON THE TISSUE BETWEEN THE PROSTATE AND PUBIC BONE AND WOULD NOT RELEASE. THE TISSUE AND JAWS OF THE INSTRUMENT HAD TO BE CUT OUT. THERE WAS BETWEEN 800CC AND 1000CC BLOOD LOSS AND A TRANSFUSION WAS NECESSARY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other| R