BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 2894417 · Received January 3, 2013

    Report

    Report Number
    3005075853-2013-00025
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 13, 2012
    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
    DE, IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VIDEO LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHILE USING THIS CLIP APPLIER ON THE CYSTIC DUCT/CYSTIC ARTERY, THE CLIPS APPLIED WERE SCISSORED. THE CASE WAS CARRIED OUT AND FINISHED BY USING A DIFFERENT DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3177 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA J4AT2G

    Patients

    Seq Age Sex Outcome Treatment
    1