BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE*ILS CURVED CIR STAPL

    MDR report key: 1923980 · Received December 14, 2010

    Report

    Report Number
    3005075853-2010-07068
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 17, 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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED. 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. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RECTUM RESECTION PROCEDURE FOR A PATIENT WITH RECTUM CANCER, THE SURGEON USED A CIRCULAR STAPLER AND A CONTOUR STAPLER. AFTER THE SURGEON CLOSED THE CONTOUR AND FIRED THE CIRCULAR, NO CRUNCH OCCURRED; THE KNIFE COULD NOT CUT AND THE STAPLES WERE NOT FORMED. THE SURGEON CHANGED TO A NEW CIRCULAR AND CONTOUR TO COMPLETE THE PROCEDURE. NOW THE PATIENT IS FINE. THE PROCEDURE WAS PROLONGED 150 MINUTES.

    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 G4T245

    Patients

    Seq Age Sex Outcome Treatment
    1