BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW LIGASURE 5MM

    MDR report key: 3061765 · Received March 29, 2013

    Report

    Report Number
    1717344-2013-00237
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Report Date
    March 8, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED DEVICE WAS RECEIVED FOR EVAL BUT THE CORD HAD BEEN CUT OFF BY THE SITE. FUNCTIONAL TESTING ON A GENERATOR COULD NOT BE PERFORMED BECAUSE OF THE CONDITION THE DEVICE WAS IN WHEN RECEIVED. AS A RESULT, THE CAUSE OF THE REPORTED EVENT COULD NOT BE VERIFIED OR DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE DID NOT SEAL. THERE WAS NO PT INJURY. ADDITIONAL QUESTIONS WERE ASKED REGARDING THE INCIDENT BUT NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129724 NEW LIGASURE 5MM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 245982X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK