BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE V SEALER/DIVIDER

    MDR report key: 2221178 · Received August 16, 2011

    Report

    Report Number
    1717344-2011-00688
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 22, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: (B)(4) 2011. THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE, IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. 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 CUSTOMER REPORTED THAT THE DEVICE WAS NOT MAKING A SEAL AND THE PROCEDURE WAS CONVERTED TO OPEN. FURTHER INFORMATION HAS NOT YET BEEN RECEIVED FROM THE SITE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R