BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE V 5 MM SEALER DIVIDER

    MDR report key: 1821162 · Received August 20, 2010

    Report

    Report Number
    1717344-2010-00585
    Event Type
    Injury
    Date Received
    August 20, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 13, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. WHEN THE DEVICE EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT DURING AN ANTERIOR RESECTION, THE KNIFE TRIGGER BECAME STIFF AND WOULD NOT RETURN. THE DEVICE WAS REMOVED WITH NO TISSUE DAMAGE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. NOTHING FELL INTO THE PT CAVITY AND THERE WAS NO PT INJURY. A PHOTO INCLUDED IN THE FILE BY COVIDIEN (B)(4) SHOWED THAT THE DEVICE KNIFE IS MISSING. ALTHOUGH REQUESTED, NO FURTHER INFO HAS BEEN MADE AVAILABLE AS TO WHETHER X-RAYS ARE AVAILABLE OR HAVE BEEN TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE V 5 MM SEALER DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other