BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP CLIP APPLIER

    MDR report key: 4891889 · Received July 6, 2015

    Report

    Report Number
    3005075853-2015-04031
    Event Type
    Malfunction
    Date Received
    July 6, 2015
    Date of Event
    June 15, 2015
    Report Date
    June 16, 2015
    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
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE WAS FIRED ON CHOLANGIOCATH. SOMETIMES THE DEVICE WAS NOT DEPLOYING CLIPS AND SOMETIMES THE DEVICE WAS SHOOTING OUT MULTIPLE CLIPS AT ONCE. THE CLIPS WERE ALSO NOT CLAMPING DOWN ALL THE WAY AND WERE SCISSORING. THE SCISSORED CLIPS WERE REMOVED AND THE CASE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434909 LIGACLIP CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1