BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 1883909 · Received October 22, 2010

    Report

    Report Number
    1717344-2010-00684
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE #: (B)(6). DATE OF INITIAL REPORT : (B)(6)2010. THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A TOTAL ABDOMINAL HYSTERECTOMY (TAH/BSO,) TISSUE BECAME LOCKED IN THE JAWS OF THE DEVICE AND THE DEVICE WOULD NOT OPEN. THE SURGEON HAD TO USE TRANSECTION TO REMOVE THE DEVICE. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 190084L

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK