BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE BLUNT TIP OPEN SEALER/DIVIDER

    MDR report key: 3821355 · Received April 28, 2014

    Report

    Report Number
    1717344-2014-00370
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 2, 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 EVAL. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE JAWS WOULD NO LONGER OPEN WHILE ON PT TISSUE DURING A LOBECTOMY. TISSUE WAS RESECTED IN ORDER TO REMOVE THE DEVICE. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254442 LIGASURE BLUNT TIP OPEN SEALER/DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 33400051X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK