BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 1850124 · Received September 21, 2010

    Report

    Report Number
    1717344-2010-00663
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 6, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A COLON PROCEDURE, THE DEVICE MADE A STRANGE SOUND AND THEN SEALING BECAME UNABLE TO BE DONE. THE SURGEON OPENED ANOTHER DEVICE AND COMPLETED THE PROCEDURE. 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) 186767L

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK