BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 3952186 · Received May 12, 2014

    Report

    Report Number
    1717344-2014-00352
    Event Type
    Malfunction
    Date Received
    May 12, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 2014
    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). 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 DURING AN OPEN OVARIAN CANCER RADICAL OPERATION, THE JAWS OF THE DEVICE COULD NOT BE REOPENED WHILE APPLIED TO TISSUE. THE SURGEON WAS ABLE TO WORK THE DEVICE OFF OF THE TISSUE BY HAND. THE PATIENT WAS NOT INJURED. THIS INCIDENT RESULTED IN A DELAY TO THE PROCEDURE OF MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284860 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 238541LX

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR