BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3030437 · Received April 2, 2013

    Report

    Report Number
    3005075853-2013-01542
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 8, 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
    VA, 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 DEVICE PLACED THE CLIP FINE. THE NEXT CLIP FELL OUT OF THE JAWS. THE DEVICE WAS CLICKED AGAIN, FIRED FINE AND THEN THE NEXT CLIP FELL OUT OF THE JAWS. ALL THE FALLEN CLIPS WERE REMOVED. THE CLIPS THAT WERE FIRED WERE FORMED CORRECTLY. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO PATIENT IMPACT. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134718 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4C31W

    Patients

    Seq Age Sex Outcome Treatment
    1