BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE BLUNT TIP OPEN SEAL/DIVIDER

    MDR report key: 3955751 · Received February 13, 2014

    Report

    Report Number
    1717344-2014-00121
    Event Type
    Malfunction
    Date Received
    February 13, 2014
    Date of Event
    January 15, 2014
    Report Date
    January 24, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REQUESTED BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SEALING COULD NOT BE COMPLETED DURING A LOBECTOMY EVEN THOUGH END TONES WERE HEARD. THERE WAS NO BLEEDING AND NO PT INJURY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95749 LIGASURE BLUNT TIP OPEN SEAL/DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1