BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3936142 · Received July 15, 2014

    Report

    Report Number
    3005075853-2014-04983
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 1, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY, JAMMING OCCURRED AND THE CLIP WAS UNFORMED. THE DEVICE WAS USED ON THE BLOOD VESSEL. IT WAS UNKNOWN WHICH FIRING OF THE DEVICE THIS EVENT OCCURRED ON. THE UNFORMED CLIP WAS REMOVED FROM THE PATIENT WITH A FORCEPS VIA A TROCAR. NO CLIPS FELL INTO THE PATIENT. THERE MIGHT HAVE BEEN UNEXPECTED RESISTANCE IN GRASPING THE TRIGGER. THERE WAS NO UNEXPECTED NOISE. THERE WAS NO TORQUING OR TWISTING OF THE DEVICE PRESENT. THE DEVICE DID NOT CLAMP SOMETHING HARD SUCH AS AN EXISTING CLIP. THE DEVICE WAS FIRED OUT OF THE PATIENT AFTER THE EVENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT THE ER420 INSTRUMENT WAS RETURNED IN GOOD VISUAL CONDITION WITH A CLIP IN THE JAWS; THE CLIP WAS REMOVED IN ORDER TO MEASURE JAWS WIDTH AND THEY WERE FOUND TO BE IN GOOD 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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY, JAMMING OCCURRED AND THE CLIP WAS UNFORMED. THE DEVICE WAS USED ON THE BLOOD VESSEL. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412128 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1