BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1022846 · Received March 25, 2008

    Report

    Report Number
    1527736-2008-01852
    Event Type
    Injury
    Date Received
    March 25, 2008
    Report Date
    March 5, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 3/25/2008. INFO NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLE PROCEDURE, THE CLIPS LOOKED AS IF THEY WERE FORMED CORRECTLY AND THE CASE WAS COMPLETED. THE NEXT DAY, IT WAS DISCOVERED THE PATIENT HAD A BILE LEAK AND A REOPERATION WAS REQUIRED. NO ADDITIONAL INFORMATION KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER FZP ETHICON ENDO SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R