BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    45MM ARTICNG

    MDR report key: 1892001 · Received November 7, 2010

    Report

    Report Number
    3005075853-2010-06335
    Event Type
    Malfunction
    Date Received
    November 7, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 15, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE (B)(4) DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED FULLY FIRED.THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED AND CUT WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ASR REVISION - RIGHT HIP. ASR XL ACETABULAR SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THORACOSCOPIC LEFT LOWER LOBECTOMY PROCEDURE, ALTHOUGH ALL THE STAPLES WERE DEPLOYED, THE STAPLES WERE MALFORMED. THE KNIFE MOVED FORWARD PROPERLY. THE EVENT OCCURRED WHEN THE DEVICE WAS FIRED ON THE BRONCHIAL TUBES BETWEEN THE LUNG BASE AND B6. THE TISSUE WAS NOT CALCIFIED, BUT THICK AND HARD. ALTHOUGH THE ARTICULATION LEVER WAS USED, IT WAS NOT FULLY BENT. IT WAS A LITTLE HARD TO GRASP THE CLOSING LEVER, BUT IT COULD BE GRASPED. ALSO, THE FIRING WAS A LITTLE HARD, BUT THE FIRING TRIGGER COULD BE GRASPED. THE EDGE OF THE BRONCHIAL TUBES WAS NOT OPENED JUST AFTER THE FIRING BECAUSE OF PRESSURE BONDING. AFTER THE RESECTED LUNG WAS REMOVED, IT WAS FOUND THAT THE STAPLE LINE HAD OPENED. ALSO, THERE WERE SOME UNFORMED STAPLES INSIDE THE THORACIC CAVITY. THE SMALL INCISION WAS BROADENED OUT A LITTLE AND ADDITIONAL SUTURE WAS PERFORMED WITH A NEEDLE-HOLDER. A NEEDLE COULD BE PRICKED EASILY AT THE TARGET TISSUE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 45MM ARTICNG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4TE3C

    Patients

    Seq Age Sex Outcome Treatment
    1