BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1905583 · Received November 23, 2010

    Report

    Report Number
    3005075853-2010-06651
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Report Date
    September 23, 2010
    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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. JAW DISENGAGED THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED WITH ONE JAW AND CAM RAMP DISENGAGED. THIS CONDITION WOULD NOT ALLOW THE JAWS TO COLLAPSE IN ORDER TO FORM THE CLIPS. THE DEVICE WAS CYCLED AND EJECTED THE REMAINING CLIPS DUE TO THE FOUND CONDITION. POSSIBLE CAUSES FOR THE FOUND CONDITION OF THE JAWS 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 DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR OVER TRAVELED. THIS FINDING IS NOT RELATED TO THE REPORTED EVENT. 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 AN UNKNOWN PROCEDURE, THE DEVICE WAS DEFECTIVE. NO OTHER INFORMATION IS AVAIALBLE. IT IS UNKNOWN HOW CASE WAS COMPLETED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4TJ03

    Patients

    Seq Age Sex Outcome Treatment
    1