BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE HS XTD DISP ELEC/CORD

    MDR report key: 3150307 · Received May 30, 2013

    Report

    Report Number
    1717344-2013-00400
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 2, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE, IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. 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 THE END OF A SEAL CYCLE WAS NOT REACHED. THE UNIT WAS EXCHANGED WITH A NEW ONE AND THIS CAUSED THE SURGERY TIME TO EXTEND MORE THAN THIRTY MINUTES. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED BUT NO RESPONSE HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238294 LIGASURE HS XTD DISP ELEC/CORD LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 245288X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK