BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3915655 · Received July 7, 2014

    Report

    Report Number
    3005075853-2014-04674
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 16, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT THE ER420 DEVICE WAS RETURNED WITH A CLIP IN JAWS AND 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, RETAINED AND FORMED THE REMAINING 14 CLIPS AS INTENDED. THE REPORTED EVENT COULD NOT BE CONFIRMED AS THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL. 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). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHEN CLIPS DID NOT HOLD, WAS THERE ANY BLEEDING OR LEAK THAT OCCURRED? NO. IF BLEEDING, PLEASE QUANTIFY AMOUNT OF BLEEDING. WERE ANY BLOOD PRODUCTS GIVEN TO PATIENT? NO. WAS THERE ANY CHANGE TO PROCEDURE OR POST-OP PATIENT CARE? NO. HOW WAS CASE COMPLETED? WITH A SECOND CLIP APPLIER DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY PROCEDURE, THE CLIPS DIDN'T HOLD. NO FURTHER INFORMATION. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393865 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA J4CU3Y

    Patients

    Seq Age Sex Outcome Treatment
    1