BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 5765837 · Received July 1, 2016

    Report

    Report Number
    3005075853-2016-03719
    Event Type
    Malfunction
    Date Received
    July 1, 2016
    Date of Event
    June 9, 2016
    Report Date
    June 10, 2016
    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). BATCH # K92029. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS USER EVER ABLE TO GET JAWS OF DEVICE OPEN DURING THE PROCEDURE: NO INFORMATION. ANYWAY, THE DEVICE DID NOT CLAMP THE PATIENT¿S TISSUE AT THE TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE ER420 DEVICE WAS RETURNED WITH NO DAMAGE IN THE EXTERNAL COMPONENTS. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. DURING THE ANALYSIS, THE DEVICE WAS CYCLED AND IT FED AND FORMED (B)(4) CLIPS. HOWEVER, UPON EACH ACTUATION OF THE TRIGGER, IT WAS NOTED THAT THE CLIPS WERE FED SLOWER THAN EXPECTED. FINALLY, IT LOCKED OUT AS INTENDED. IT IS KNOWN FROM THE HISTORY OF THE DEVICE THAT A POSSIBLE CAUSE FOR THE SLOW FEEDING ISSUE IS THE SILICONE THAT GET VISCOUS; THE SILICONE IS APPLIED DURING THE MANUFACTURING PROCESS; HOWEVER, NO CONCLUSION COULD BE REACHED AS WHAT MAY HAVE CAUSED THIS CONDITION. THE BATCH HISTORY RECORD WAS REVIEWED AND NO DEFECTS, NCR¿S OR PROTOCOLS RELATED TO THE COMPLAINT, WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE JAWS DID NOT OPEN WHEN THE DEVICE WAS FIRED FOR FUNCTIONALITY WITHOUT CLAMPING TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419928 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1