BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 1210041 · Received October 21, 2008

    Report

    Report Number
    1717344-2008-00478
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 23, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CORD HAD BEEN CUT OFF THE DEVICE BY THE SITE BUT WAS SPLICED BACK ON TO PERFORM TESTING. THE INCIDENT WAS EVALUATED AND FOUND TO FUNCTION WITHIN SPECIFICATION. ADDITIONAL TESTING WAS DONE BY PERFORMING MULTIPLE SEALS OF VARIOUS SIZES ON PORCINE TISSUE, AND ALL SEAL CYCLES WERE COMPLETED SATISFACTORILY. (SEE SCANNED PAGES).

    Description of Event or Problem · 1

    THE REPORT STATES THAT THE INSTRUMENT DID NOT SEAL BILATERALLY. THERE WAS NO REGRASP ALERT, BUT AN END TONE, INDICATING A COMPLETED SEAL CYCLE. TISSUE WAS FUSED BUT NOT COMPLETELY SO THE SURGEON COMPLETED THE PROCEDURE WITH SUTURES. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 144709

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK