BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW LIGASURE 5MM

    MDR report key: 3810467 · Received April 15, 2014

    Report

    Report Number
    1717344-2014-00321
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 20, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    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 INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WAS PROVIDING REGRASP ALARMS DURING THE CASE. THE CASE WAS DELAYED BY 30 MINUTES OR MORE. THE PT HAS BEEN REPORTED TO BE IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230736 NEW LIGASURE 5MM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 238631X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK