BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX - CLIP APPLIER

    MDR report key: 2111272 · Received June 2, 2011

    Report

    Report Number
    3005075853-2011-02239
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 22, 2011
    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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED WITH JAWS IN THE CLOSED POSITION. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS WITHOUT ANY DIFFICULTIES NOTED; ONE J SHAPED CLIP WAS RELEASED. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE MALFORMED CLIP. UPON FIRING OF THE DEVICE, THE REMAINING CLIPS WERE CONFORMING ACCORDING TO OUR MANUFACTURING SPECIFICATIONS. A DESIGN CHANGE WAS IMPLEMENTED TO MINIMIZE THE OCCURRENCE OF THIS ISSUE. PLEASE NOTE THE RETURNED DEVICE WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF THIS CHANGE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE JAMMED AFTER FIRING SEVERAL CLIPS. NO OTHER INFORMATION IS AVAILABLE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1