BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX CLIP APPLIER

    MDR report key: 3893527 · Received June 25, 2014

    Report

    Report Number
    3005075853-2014-04357
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 29, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF FURTHER DETAILS ARE RECEIVED AND/OR DEVICE IS RECEIVED AND ANALYZED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT. THE DEVICE WILL NOT BEEN RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE MISFIRED. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ONE DEVICE WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371143 LIGAMAX CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1