BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 2272312 · Received August 23, 2011

    Report

    Report Number
    1717344-2011-00742
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 23, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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 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 TOTAL ABDOMINAL HYSTERECTOMY, THE JAWS OF THE DEVICE COULD NOT BE RE-OPENED WHILE IN USE ON THE GREATER OMENTUM. THE DEVICE WAS REMOVED BY RESECTING THE TISSUE ADJACENT TOT HE HAWS. THE SURGEON OPENED ANOTHER INSTRUMENT 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) 209832LX

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK