BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE V SEALER/DIVIDER

    MDR report key: 1001957 · Received February 20, 2008

    Report

    Report Number
    1717344-2008-00051
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    January 24, 2008
    Report Date
    January 24, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE IT HAS NOT BEEN REC'D FOR EVAL. ADDITIONAL QUESTIONS HAVE ALSO BEEN ASKED OF THE CUSTOMER. IF THE SAMPLE IS REC'D OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE REPORT STATED THAT DURING A LAPAROSCOPIC NEPHRECTOMY, THE LIGASURE V WAS BEING USED TO SEAL AND TRANSECT TISSUE. THE SURGEON NOTICED THAT SOME OF THE TISSUES WERE BLEEDING, SO THE PROCEDURE WAS CONVERTED TO A LAPAROTOMY. THE AMOUNT OF BLEEDING WAS LESS THAN 200 CC'S. THE PT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE V SEALER/DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 132430

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention