BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 4220907 · Received November 3, 2014

    Report

    Report Number
    3005075853-2014-07573
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 28, 2014
    Report Date
    October 28, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE FIRST AND SECOND FIRINGS WERE FINE. ON THE THIRD FIRING WHEN THEY WENT TO PRE-LOAD THE DEVICE IT ONLY PARTIALLY PRE-LOADED; ON FIRING THE CLIP DID NOT FORM. ALL REMAINING CLIPS WERE FIRED WITHOUT FORMING. THE CASE WAS COMPLETED WITH ANOTHER DEVICE OF A DIFFERENT PRODUCT CODE. IT WAS NOT KNOWN IF A CHOLANGIOGRAM WAS DONE WITH THIS PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THE DEVICE HAS BEEN DISCARDED AND NO DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702170 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA L4F12C

    Patients

    Seq Age Sex Outcome Treatment
    1