BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3935781 · Received July 15, 2014

    Report

    Report Number
    3005075853-2014-04968
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 30, 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
    MS, 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 TWO CLIPS WERE DEPLOYED SUCCESSFULLY. ON THE THIRD FIRING THE CLIP DID NOT DEPLOY. ON THE FOURTH FIRING THE CLIP WAS NOT CLAMPING THE TISSUE. THE PROCEDURE WAS COMPLETED WITHOUT IMPACT TO THE PATIENT. DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412628 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA L4E79A

    Patients

    Seq Age Sex Outcome Treatment
    1