BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 2122315 · Received June 13, 2011

    Report

    Report Number
    3005075853-2011-02390
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 20, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE EVENT REPORTED, THE DEVICE WAS TESTED FOR FUNCTIONALITY. IT WAS FIRED AND TWO UNFORMED CLIPS DROPPED DOWN FROM THE JAWS. THE UNFORMED CLIPS WERE DETERMINED TO BE CAUSED BY THE FAILURE OF THE ANTI-BACKUP FEATURE. A POSSIBLE CAUSE FOR THIS CONDITION MAY BE STOPPING THE FIRING SEQUENCE AND PULLING THE TRIGGER OPEN. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHEN THE DOCTOR FIRED THE DEVICE ON THE CYSTIC DUCT, THE DEPLOYED CLIP HAD A GAP AT THE ACRAL PART AND COULD NOT BE FORMED PROPERLY. AN UNEXPECTED NOISE WAS NOT HEARD. ALSO, THE DOCTOR DID NOT FEEL ANY UNEXPECTED RESISTANCE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THE NURSE COMMENTED THAT THE CLIP HAD BEEN FORMED PROPERLY WHEN THE DEVICE WAS HAD BEEN FIRED ON GAUZE TO CHECK ITS FUNCTION BEFORE USE ON THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1