BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1081080 · Received July 21, 2008

    Report

    Report Number
    3005075853-2008-00599
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 18, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D4; H4: INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT THE INITIAL CLIP DID NOT FORM COMPLETELY WHEN FIRING ON THE COMMON BILE DUCT. THEY USED ANOTHER LIKE DEVICE TO COMPLETE WITH NO PATIENT CONSEQUENCE. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER FZP ETHICON ENDO-SURGERY, LLC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1