BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 2082662 · Received April 28, 2011

    Report

    Report Number
    1717344-2011-00316
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 25, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: (B)(4) 2011. THE INCIDENT SAMPLE HAS BEEN REQUESTED, BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. 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 A HYSTERECTOMY, THE DEVICE JAWS BECAME LOCKED ON TISSUE. THE DEVICE WAS CUT FROM TISSUE IN ORDER TO REMOVE IT. THE SURGEON OPENED ANOTHER DEVICE AND COMPLETED THE PROCEDURE WITH NO FURTHER DIFFICULTIES. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 200545L

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK