BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX CLIP APPLIER

    MDR report key: 4243412 · Received November 11, 2014

    Report

    Report Number
    3005075853-2014-07812
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 23, 2014
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE 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. DURING ANALYSIS THE JAWS OPEN AND CLOSE AS INTENDED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: CUSTOMER CALLED BACK WITH ADDITIONAL INFORMATION AND THE FILE HAS BEEN UPDATED: THERE WAS LESS THAT 100CC OF BLEEDING AND IT WAS CONTROLLED WITH CAUTERY ONCE THE DEVICE WAS REMOVED WITH THE DISSECTOR. THE PROCEDURE WAS OVER AT THAT POINT AND THERE WAS NO PATIENT CONSEQUENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GYNECOLOGICAL PROCEDURE, THE DEVICE FIRED AND WAS STUCK ON TISSUE AND WOULD NOT OPEN. THEY HAD TO USE A MARYLAND DISSECTOR TO REMOVE THE DEVICE. THERE WAS NO BLEEDING REPORTED. THERE WAS NO INFORMATION ON HOW THE PROCEDURE WAS COMPLETED. THE DEVICE WAS LEFT IN MATERIALS WITH A NOTE AND NO OR CONTACTS. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725672 LIGAMAX CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA L4EZ8F

    Patients

    Seq Age Sex Outcome Treatment
    1