BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 2221894 · Received August 24, 2011

    Report

    Report Number
    3005075853-2011-03486
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    July 20, 2011
    Report Date
    August 2, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. 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 STOMACH RESECTION PROCEDURE, JEJUNUM-OESOPHAGUS ANASTOMOSIS, AFTER THE SURGEON FIRED THE DEVICE, THE TISSUE COULD NOT BE CUT COMPLETELY. THEN THE SURGEON USED KNIFE TO CUT. BUT THE ANASTOMOSIS HAD TRAUMA. THE SURGEON OPENED THE CHEST TO ANASTOMOSE. THE SURGERY WAS DELAYED TWO HOURS. NOW THE PATIENT IS FINE. ADDITIONAL INFORMATION BEING REQUESTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REQUESTED ON (B)(4) 2011 AND TO DATE, NO MORE INFORMATION HAS BEEN RECEIVED.

    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 G4RU2V

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR