BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3142901 · Received June 3, 2013

    Report

    Report Number
    3005075853-2013-02748
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 10, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE INITIAL REPORTER WAS UNCOMFORTABLE PROVIDING THE IDENTITY OF THE SURGEON WHO PERFORMED THE PROCEDURE. HE ADVISED THAT THE PATIENT HAS DONE WELL IN THE POST OPERATIVE PERIOD AND THERE IS NO FURTHER INFORMATION AVAILABLE. 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 FOLLOWING A LAP CHOLECYSTECTOMY PROCEDURE, THE PATIENT WAS STINTED FOR A BILE LEAK IN THE POST OPERATIVE PERIOD. THE PATIENT HAS RECOVERED WELL. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243841 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention