BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE V SEALER/DIVIDER

    MDR report key: 807452 · Received January 17, 2007

    Report

    Report Number
    1717344-2007-00016
    Event Type
    Injury
    Date Received
    January 17, 2007
    Date of Event
    December 19, 2006
    Report Date
    December 19, 2006
    Manufacturer
    VALLEYLAB QA
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS ALWAYS A CONCERN WHEN VALLEYLAB IS NOTIFIED OF A PRODUCT COMPLAINT. WE AS A MFR STRIVE FOR EXCELLENCE IN CONSTANTLY IMPROVING OUR PRODUCTS QUALITY AND SURGICAL CARE. A MORE COMPLETE DESCRIPTION OF THE INCIDENT DESCRIBED IN THE RECEIVED REPORT INCLUDING RELEVANT EVENTS PRIOR TO AND SUBSEQUENT TO THE ACTUAL INCIDENT HAS BEEN SOUGHT (INCLUDING ADD'L PT STATUS DETAILS). THE FILE WILL BE UPDATED WHEN ADD'L INFO IS RECEIVED.

    Description of Event or Problem · 1

    PROCEDURE: NOT REPORTED. REPORTEDLY, THE INSTRUMENT HAD BEEN IN USE FOR ABOUT 20 MINUTES WHEN THE SURGEON RATCHETED THE INSTRUMENT OVER TISSUE, COMPLETED THE SEAL CYCLE, DIVIDED THE TISSUE. THE JAWS LOCKED ON TISSUE AND WOULD NOT RELEASE. IN AN ATTEMPT TO OPEN THE JAWS, THE FORWARD RING OF THE HANDLE BROKE. THE INSTRUMENT HAD TO BE CUT FROM THE TISSUE AND A NEW INSTRUMENT WAS OPENED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE V SEALER/DIVIDER ELECTROSURGICAL DEVICE GEI VALLEYLAB QA * 106016

    Patients

    Seq Age Sex Outcome Treatment
    1 YR