BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3001177 · Received March 13, 2013

    Report

    Report Number
    3005075853-2013-01219
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 1, 2013
    Report Date
    March 1, 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
    IT
    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 CHOLECYSTECTOMY PROCEDURE, ON AN UNKNOWN DATE, THE CLIPS APPLIED BY THIS CLIP APPLIER FAILED TO CLOSE PROPERLY. THE CASE WAS CARRIED OUT AND FINISHED BY OPENING A NEW ER420 FROM A DIFFERENT LOT. NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE DEVICE INVOLVED WAS UNFORTUNATELY DISCARDED BY THE HOSPITAL AND WON'T BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106062 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA J4A67N

    Patients

    Seq Age Sex Outcome Treatment
    1