BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** CLIP APPLIER - SMALL

    MDR report key: 4110999 · Received September 23, 2014

    Report

    Report Number
    3005075853-2014-06627
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    September 22, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDO
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 AN UNKNOWN PROCEDURE, THE CLIPS WERE CROSSING. THE CASE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592354 LIGACLIP** CLIP APPLIER - SMALL GDO ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1