BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW LIGASURE 5MM

    MDR report key: 1903024 · Received November 12, 2010

    Report

    Report Number
    1717344-2010-00813
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 19, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE ON THE OVARIAN PEDICLE DURING A HYSTERECTOMY, THERE WAS AN END TONE INDICATING A COMPLETED SEAL CYCLE, BUT NO SEAL WAS COMPLETED. THE SITE TRIED THE INSTRUMENT ON ANOTHER GENERATOR WITH THE SAME RESULT. THERE WAS NO PT INJURY. ANOTHER DEVICE WAS USED AND THE SURGEON HAD THE SAME ISSUE. THIS DEVICE CAN BE FOUND ON MFR REPORT# 1717344-2010-00814.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEW LIGASURE 5MM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 189700

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK