BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2013399 · Received March 10, 2011

    Report

    Report Number
    3005075853-2011-00972
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    November 30, 2010
    Report Date
    December 14, 2010
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). JAWS. THE ANALYSIS RESULTS OF DEVICE (A) FOUND THAT IT WAS RETURNED EMPTY AND WITH THE LOCK OUT MECHANISM BROKEN AS IT WAS FIRED THROUGH. THE INSTRUMENT IS DESIGNED TO LOCK OUT AFTER ALL THE CLIPS HAVE BEEN FIRED; THEREFORE A POTENTIAL CAUSE OF THE CUSTOMER REPORTED EXPERIENCE IS THE FIRING OF ALL OF THE CLIPS AND THE INSTRUMENT "WOULD NOT FIRE" (ACTIVATION OF THE LOCK OUT MECHANISM). THE INSTRUMENT HAS AN ORANGE INDICATOR THAT APPEARS ON THE TOP OF THE HANDLE AS A REFERENCE FOR THE USER AS TO THE QUANTITY OF CLIPS REMAINING. THE ANALYSIS RESULTS FOUND THAT THE DEVICE (B) WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS NOT VISIBLE. THIS FINDING IS NOT RELATED WITH THE INCIDENT REPORTED. BATCH # G9L57X MFG DATE: 9/30/2010 EXP DATE: 08/30/2015. 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 AN UNKNOWN PROCEDURE, BOTH DEVICES JAMMED. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. NO ADVERSE CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4U206

    Patients

    Seq Age Sex Outcome Treatment
    1