BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 2042629 · Received April 6, 2011

    Report

    Report Number
    3005075853-2011-01388
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 11, 2011
    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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A PICTURE WAS RETURNED AND REVIEW BY EES FIELD QUALITY ENGINEER. THE SUMMARY IS BELOW: "ONE OF THE 4 CLIPS IN THE PHOTOGRAPHS HAS ITS LEGS SIGNIFICANTLY MISALIGNED. BASED ON THE ANGLE AT WHICH THE CLIP LEGS ARE CONTACTING THE STRUCTURE, IT APPEARS AS IF THE DEVICE WAS ROTATED FOR VISIBILITY. TAKING INTO ACCOUNT THE CLOSE PROXIMITY OF THE ADJACENT CLIP, THE DEVICE JAW ON THE UNDERSIDE OF THE STRUCTURE MAY HAVE CAPTURED PART OF THE ADJACENT CLIP WITHIN THE JAWS. COUPLE THIS WITH THE ROTATIONAL FORCE THAT APPEARS TO HAVE BEEN APPLIED. THE CLIP JAWS MAY HAVE BECOME MISALIGNED DURING THE FIRING STROKE. WHEN THIS HAPPENS THE FORCE CREATING THE MISALIGNMENT ALSO GETS IMPARTED TO THE CLIP LEGS FORCING ONE OR BOTH OUT OF THE CLIP TRACK. ONCE THE CLIP LEGS ARE OUT OF THE CLIP TRACK THE JAWS CAN NO LONGER KEEP THEM IN ALIGNMENT DURING THE JAW CLOSING. HENCE THE CLIP LEGS WILL CROSS. THE ABOVE OBSERVATIONS ARE BASED ON EXPERIENCE, REPLICATION OF SIMILAR CLIP FORMATION, AND UNDERSTANDING THE MECHANICS OF CLIP FORMATION AND APPLIED TO WHAT I CAN REASON FROM THE PHOTOGRAPHS." THE ANALYSIS RESULTS FOUND THAT THE 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. NO SCISSORED CLIPS WERE NOTED DURING EVALUATION; THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL AND CONFORMING TO OUR MANUFACTURING SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE THE CLIPS WERE STICKING IN THE JAWS AND THE CLIPS WERE SCISSORED WHEN FIRED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA H4354C

    Patients

    Seq Age Sex Outcome Treatment
    1