BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW LIGASURE 5MM

    MDR report key: 3150304 · Received May 30, 2013

    Report

    Report Number
    1717344-2013-00395
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    May 5, 2013
    Report Date
    May 7, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE WAS RETURNED, EVALUATED AND FOUND TO FUNCTION WITHIN SPECIFICATION. THE DEVICE WAS TESTED FOR ACTIVATION AND SEALING FUNCTION ON SIMULATED TISSUE WITH ACCEPTABLE RESULTS. ADDITIONAL TESTING WAS DONE BY PERFORMING MULTIPLE SEALS OF VARIOUS SIZES ON PORCINE TISSUE AND ALL SEAL CYCLES WERE COMPLETED SATISFACTORILY. WE WERE UNABLE TO CONFIRM THE CUSTOMER'S REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE DEVICE WAS NOT SEALING. THERE WAS NO PATIENT INJURY. THE SITE HAD NO FURTHER INFORMATION REGARDING THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238293 NEW LIGASURE 5MM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 247763X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK