BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3891593 · Received June 24, 2014

    Report

    Report Number
    3005075853-2014-04306
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    February 14, 2014
    Report Date
    March 24, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) = MALFORMED CLIP, CLIP JAMMED, EJECTED CLIP. THE ANALYSIS RESULTS OF THE ER420 DEVICE FOUND THAT IT WAS RECEIVED WITH A MALFORMED CLIP FED SIDEWAYS AND JAMMED IN THE JAWS. THE JAWS WERE FOUND PROPERLY ALIGNED. IN AN ATTEMPT TO REPLICATE THE INCIDENT REPORTED THE DEVICE WAS FUNCTIONALLY EVALUATED. UPON FIRING OF THE DEVICE, THE REMAINING (B)(4) 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 CONDITION. 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, THE CLIPS WOULD NOT ADVANCE; THEY GOT STUCK IN THE DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368921 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4CT3R

    Patients

    Seq Age Sex Outcome Treatment
    1