BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1961803 · Received January 14, 2011

    Report

    Report Number
    3005075853-2011-00192
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 21, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EMPTY. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. WHEN TESTING THE DEVICE FOR FUNCTIONALITY IT WAS NOTED TO BE EMPTY, LOCKED OUT AND WITH THE ORANGE INDICATOR OVER TRAVELED. THE EVENT COULD NOT BE CONFIRMED DUE TO THE RETURNED CONDITION OF THE DEVICE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE JAW "BECAME NOT TO OPEN", SO THE JAW WAS OPENED BY RETURNING THE TRIGGER TO THE HOME POSITION BY HAND. THE EVENT OCCURRED ABOUT FIVE TIMES IN A ROW. IT WAS UNKNOWN WHICH FIRING THE EVENT OCCURRED ON. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4U340

    Patients

    Seq Age Sex Outcome Treatment
    1