BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1083270 · Received July 29, 2008

    Report

    Report Number
    3005075853-2008-00760
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    July 3, 2008
    Report Date
    July 7, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY PROCEDURE, THE HANDLE FELT A LITTLE HARD AND THE JAW COULD NOT BE OPENED AND MADE A CRASHING NOISE. SCISSORS WERE USED TO RESECT THE DEVICE AND CLIP FROM THE TISSUE ENDOSCOPICALLY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention