BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE STD DISP ELECT/CORD

    MDR report key: 3385867 · Received September 20, 2013

    Report

    Report Number
    1717344-2013-00745
    Event Type
    Injury
    Date Received
    September 20, 2013
    Report Date
    August 21, 2013
    Manufacturer
    COVIDIEN LLP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IN A LITERATURE REVIEW FROM HPB, "LIVER TRANSECTION USING THE LIGASURE SEALING SYSTEM" 2008; 10: 239-243. A PT HAD POSTOPERATIVE HEMORRHAGE. NO OTHER DETAILS ARE AVAILABLE FROM THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474439 LIGASURE STD DISP ELECT/CORD LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| R