BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3844130 · Received June 2, 2014

    Report

    Report Number
    3005075853-2014-03722
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Report Date
    April 7, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT IS MEANT BY "2X ONLY 3 CLIPS?" PLEASE PROVIDE MORE DETAIL REGARDING SPECIFIC ISSUE. WHAT IS MEANT BY "1X DID NOT FUNCTION AT ALL?" RESPONSE FROM THE AFFILIATE: AS MENTIONED IN THE COMPLAINT FORM, 3 DEVICES OF ER420 WERE USED DURING THE SAME PROCEDURE. WITH TWO DEVICES, ONLY 3 CLIPS COULD BE ADVANCED AND PLACED. THE THIRD DEVICE DID NOT FUNCTION AT ALL; THAT MEANS NO CLIPS COULD BE PLACED. THE ANALYSIS RESULTS OF THE ER420 DEVICE FOUND THAT IT WAS RECEIVED IN GOOD VISUAL CONDITION. IN ADDITION, 1 MALFORMED CLIP WAS RECEIVED INSIDE THE PLASTIC BAG. IN AN ATTEMPT TO REPLICATE THE INCIDENT REPORTED THE DEVICE WAS FUNCTIONALLY EVALUATED. UPON TESTING THE DEVICE FOR FUNCTIONALITY THE DEVICE WAS CYCLED, FED, AND FORMED 2 CONFORMING CLIPS AS INTENDED AND THE REMAINING 17 CLIPS WERE NOT PROPERLY FED INTO THE JAWS, CAUSING THE CLIP TO BE FED SIDEWAYS AND EJECTED; FINALLY, IT LOCKED OUT AS INTENDED. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE FOUND FEEDING ISSUE. HOWEVER AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE OF THE DROPPING OR EJECTED CLIPS. 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 TWICE ONLY THREE CLIPS AND ONCE DID NOT FUNCTION AT ALL. NO FURTHER INFORMATION IS AVAILABLE. NO PATIENT CONSEQUENCES REPORTED. PROCEDURE WAS COMPLETED WITH SAME LIKE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322648 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4CC1V

    Patients

    Seq Age Sex Outcome Treatment
    1