BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAURE V SEALER/DIVIDER

    MDR report key: 1082439 · Received July 21, 2008

    Report

    Report Number
    1717344-2008-00335
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 25, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS BEEN REQUESTED BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE REPORT STATED THAT THE INSTRUMENT WAS USED TO SEAL THE IMA DURING A LOW ANTERIOR RESECTION. THE INSTRUMENT WAS CLOSED ON THE VESSEL, ACTIVATED AND AUDIBLE END TONE WERE HEARD INDICATING THE SEAL WAS COMPLETE. THE JAWS WERE RELEASED RESULTING IN BLEEDING AT THE SITE OF THE SEAL. THE INSTRUMENT CONTINUED TO FAIL IN ATTEMPTS TO SEAL THE VESSEL. A NEW DEVICE WAS OPENED AND USED AND IT WORKED FINE FOR THE REST OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAURE V SEALER/DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 138220

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK FORCETRIAD ENERGY PLATFORM - SERIAL NUMBER UNK