BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE V SEALER/DIVIDER

    MDR report key: 2851361 · Received October 31, 2012

    Report

    Report Number
    3006451981-2012-00188
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 12, 2012
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WOULD NOT CAUTERIZE AND WAS STICKING TO TISSUE. THERE WAS NO PT INJURY. NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE V SEALER/DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S2EB012X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK