BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE*ILS CURVED CIR STAPL

    MDR report key: 1873425 · Received October 19, 2010

    Report

    Report Number
    3005075853-2010-05925
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 28, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    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 DEVICE ARRIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER WAS PRESENT AND CUT AND THERE WERE NO STAPLES PRESENT, INDICATING THAT THE DEVICE ACHIEVED A FULL FIRING STROKE. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY. IT FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN AUTOMATED VISION SYSTEM, AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL GASTRECTOMY PROCEDURE, THE DEVICE WAS USED TO ANASTOMOSE THE ESOPHAGUS AND THE JEJUNUM. ALTHOUGH THE STAPLES WERE PARTIALLY (1/3) DEPLOYED ON THE ESOPHAGUS, THE OTHER PART WAS NOT ANASTOMOSED. BESIDES, THE STAPLES OF THE JEJUNUM SIDE WERE NOT DEPLOYED. THE DOUGHNUT WAS FORMED PROPERLY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THE DOCTOR COMMENTED THAT THERE WAS NO DIFFICULTY IN FIRING. SINCE INFLAMMATION AT THE ANASTOMOSIS SITE WAS FOUND, THE PATIENT IS BEING MONITORED AT THE MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE*ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4RC6N

    Patients

    Seq Age Sex Outcome Treatment
    1