BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 2042140 · Received April 6, 2011

    Report

    Report Number
    3005075853-2011-01374
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 21, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE SURGEON PUT THE DEVICE THROUGH A 12MM TROCAR. ONCE THE DEVICE WAS INSERTED, HE SAW A CLIP IN THE JAWS AND TRIED TO FIRE PLASTIC TO PLASTIC ON THE UTERINE ARTERY. THE CLIP JUST FELL OUT OF THE JAWS. HE RETRIEVED THE CLIP AND TRIED TO USE THE DEVICE AGAIN. THE SAME THING HAPPENED. THEY OPENED FOUR MORE DEVICES AND THE SAME THING HAPPENED EVERY TIME. THEY COMPLETED THE CASE WITH A DIFFERENT PRODUCT. THERE WERE NO PATIENT CONSEQUENCES. THREE DEVICES WERE DISCARDED.

    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