BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX- CLIP APPLIER

    MDR report key: 2160049 · Received July 13, 2011

    Report

    Report Number
    3005075853-2011-02873
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    April 29, 2011
    Report Date
    May 5, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED WITH ONE JAW AND CAM RAMP DISENGAGED. THIS CONDITION WOULD NOT ALLOW THE JAWS TO COLLAPSE IN ORDER TO BE REMOVED FROM THE TROCAR. POSSIBLE CAUSES FOR THIS CONDITION MAY BE INADVERTENT FORCE, TWISTING OR PRESSURE BEING PLACED ON THE DEVICE JAWS, USING THE JAWS OF THE DEVICE AS A DISSECTOR/RETRACTOR OR DAMAGE TO THE JAWS WHILE ENTERING THE TROCAR. IN ADDITION, THE SHAFT WAS NOTED BROKEN AT DISTAL WITH LOSE OF MATERIAL; THE INTERNAL COMPONENTS WERE EXPOSED. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THIS CONDITION. 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 WAS BEING USED WITH A COMPETITIVE TROCAR DEVICE. THE DEVICE STUCK IN THE TROCAR AND WOULD NOT RELEASE OR DEPLOY A CLIP DUE TO ITS ENTRY POSITION. THE TROCAR IS WITH THE DEVICE IN THE RETURN PACKAGE DUE TO THEY COULD NOT RELEASE THEM APART. THEY COMPLETED THE PROCEDURE WITH A NEW LIKE DEVICE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1