BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW LIGASURE 5 MM

    MDR report key: 1843659 · Received September 10, 2010

    Report

    Report Number
    1717344-2010-00633
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 16, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SITE HAS INDICATED THAT THE INCIDENT SAMPLE HAS BEEN DISCARDED. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A COLON PROCEDURE, THE DEVICE WORKED FINE WHILE MOBILIZING COLON LAPAROSCOPICALLY. THE COLON WAS MOVED OUTSIDE OF THE PATIENT AND THE SURGEON WAS TAKING VESSELS WITH THE DEVICE IN AN OPEN FASHION. DURING THIS PORTION OF THE SURGERY, THE SURGEON NOTICED A SECTION OF COLON WHICH HAD BEEN SEALED DURING LAPAROSCOPIC PORTION WAS NOW OOZING. THE SURGEON RESEALED THE AREA WITH THE DEVICE AND HEARD AN END TONE, INDICATING A COMPLETED SEAL CYCLE, BUT STILL NOTICED THE OOZING. THE SURGEON SEALED A THIRD TIME AND GOT A COMPLETE SEAL. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK