BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 2964252 · Received February 15, 2013

    Report

    Report Number
    3005075853-2013-00682
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    February 5, 2013
    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, US
    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 LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS SCISSORED. THE DEVICE CAME OUT OF A KIT AND THE CLIPS ARE SCISSORING FROM THE 1ST CLIP AND FIRINGS AFTER IT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67657 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)