BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 2961089 · Received February 14, 2013

    Report

    Report Number
    3005075853-2013-00614
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    January 31, 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
    OH, 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 WHEN SPEAKING WITH THE SURGEON AT A CUSTOMER VISIT, THE SURGEON STATED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS WERE EJECTING FROM THE DEVICE. THIS OCCURRED BETWEEN THE FIRST AND FIFTH CLIP. THE SURGEON COMPLETED THE PROCEDURE WITH THE DEVICE AND THERE WAS NO PATIENT CONSEQUENCE. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65213 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1