BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 2911625 · Received August 29, 2007

    Report

    Report Number
    1717344-2007-00270
    Event Type
    Malfunction
    Date Received
    August 29, 2007
    Date of Event
    August 3, 2007
    Report Date
    August 3, 2007
    Manufacturer
    VALLEYLAB
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: (B)(4) 2007. VALLEYLAB'S DIRECTOR OF MEDICAL CLINICAL AFFAIRS HAS CONTACTED THE OPERATING SURGEON AND OFFERED TO DISCUSS THIS INCIDENT. TO DATE THE OPERATING SURGEON HAS NOT RESPONDED. IF FURTHER INFO PERTINENT TO THIS INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE MADE.

    Description of Event or Problem · 1

    THE REPORT STATED THAT DURING A TOTAL ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY, THE LIGASURE IMPACT WAS USED FOR SEALING AND DISSECTION. HOWEVER, AFTER SEALING THE UTERINE VESSELS AND THE CARDINAL LIGAMENT, OOZING BLEEDING WAS NOTED AND THE SURGEON USED SUTURE TO SECURE THE VESSELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI VALLEYLAB UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK