BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1230506 · Received November 10, 2008

    Report

    Report Number
    3005075853-2008-02914
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    October 20, 2008
    Report Date
    October 21, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY - THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. IT WAS TESTED FOR FUNCTIONALITY, AND IT DID OPEN AND CLOSE WITHOUT ANY DIFFICULTIES. WHEN TESTING THE DEVICE FOR FUNCTIONALITY, IT WAS NOTED TO BE EMPTY AND THE LOCKOUT WAS FIRED THROUGH. WHILE WE WERE UNABLE TO RECREATE THE EVENT, WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLE PROCEDURE, THE DEVICE WAS BEING USED TO CLIP THE CYSTIC ARTERY. THE DEVICE WOULD NOT RELEASE SO THEY HAD TO CONVERT TO OPEN. IT IS UNKNOWN HOW THE DEVICE WAS REMOVED FROM THE ARTERY, OR IF IT HAD FIRED ANY SUCCESSFUL CLIPS. THE PATIENT IS OKAY.

    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