BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1021963 · Received March 11, 2008

    Report

    Report Number
    1527736-2008-01444
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    January 28, 2008
    Report Date
    February 22, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 3/11/2008. INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEW DAYS AFTER A LAP CHOLE PROCEDURE, THE PATIENT PRESENTED ABDOMINAL PAIN AND A BILE LEAK WAS FOUND. IT IS UNKNOWN HOW THE SURGEON TREATED THE LEAK. SEVERAL DAYS AFTER THE PATIENT WAS TREATED FOR THE LEAK, THE PATIENT WAS STILL EXPERIENCING PAIN. THEY RE-OPERATED AND DRAINED A SIGNIFICANT AMOUNT OF FLUID. THE PATIENT IS OKAY. THE SURGEON STATED THE CLIP HAD SLIPPED OFF THE BILE DUCT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention