BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 3002651 · Received February 13, 2013

    Report

    Report Number
    1717344-2013-00088
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    November 29, 2012
    Report Date
    November 26, 2012
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER ORIGINALLY REPORTED THAT DURING A LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY THE DEVICE BECAME DIFFICULT TO OPEN AND WAS REMOVED MANUALLY FROM TISSUE WITH NO DAMAGE OR PT INJURY. A PHOTO RECEIVED SHOWS THAT THE DEVICE KNIFE IS EXPOSED FROM BEYOND THE JAWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63884 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 229389LX

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK