BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE PRECISE

    MDR report key: 1063342 · Received June 19, 2008

    Report

    Report Number
    1717344-2008-00281
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 10, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS BEEN REQUESTED BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE INITIAL REPORT STATED THAT WHEN THE SEALING CYCLE WAS COMPLETED, THE SURGEON OBSERVED A BLUE COLOR ON THE TISSUE THAT APPEARED TO BE FROM THE JAWS OF THE INSTRUMENT. AFTER THE SEAL CYCLE IN WHICH THEY NOTICED THIS, THEY CHANGED THE DEVICE TO COMPLETE THE PROCEDURE. DURING THE USE OF THE INCIDENT DEVICE, THERE WERE NO OTHER ISSUES NOTICED IN THE SEALING PROCESS. AN INQUIRY WAS MADE TO THE HOSPITAL TO DETERMINE IF THE BLUE TISSUE "WHICH APPEARED LIKE A TATOO", WAS REMOVED. THEY REPORTED IT WAS NOT REMOVED AND THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE PRECISE LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 134832

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other