BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 1780317 · Received July 27, 2010

    Report

    Report Number
    3005075853-2010-04270
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 16, 2010
    Report Date
    June 29, 2010
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WASHER UNCUT. (B)(6). THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION WITHOUT STAPLES PRESENT AND WITH THE BREAKAWAY WASHER UNCUT, INDICATING THAT THE DEVICE HAD NOT BEEN FIRED THROUGH A FULL FIRING STROKE OR POSSIBLY THAT THE ORANGE INDICATOR WAS NOT FULLY INTO THE SAFE GREEN FIRING RANGE. IT SHOULD BE NOTED THAT IF THE INDICATOR IS NOT FULLY WITHIN THE GREEN RANGE OF THE GAP SETTING SCALE OR IF THE FIRING HANDLE IS NOT FIRMLY SQUEEZED USING STEADY PRESSURE UNTIL THE FIRING HANDLE IS FULLY PARALLEL TO THE INSTRUMENT HANDLE, STAPLES COULD BE DEPLOYED WITHOUT COMPLETELY FORMING AND WITHOUT CUTTING THE WASHER. WHEN EITHER OR BOTH OF THESE SCENARIOS OCCUR, THE DEVICE WILL NOT TRANSECT THE TISSUE COMPLETELY RESULTING IN DIFFICULTIES TO REMOVE THE DEVICE. FOR MORE INFORMATION PLEASE REFER TO THE INSTRUCTIONS FOR USE. THE DEVICE WAS RELOADED WITH STAPLES AND TESTED FOR FUNCTIONALITY; THE DEVICE 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 LOW ANTERIOR RESECTION PROCEDURE, A COMPETITIVE DEVICE LOADING THE GREEN CARTRIDGE WAS USED TO CLOSE THE RECTUM. AFTER THAT, THE DEVICE WAS FIRED TO ANASTOMOSE. WHEN THE DEVICE WAS REMOVED, IT WAS FOUND THAT THE BOWEL WAS NOT ANASTOMOSED. THE SITE WAS CUT ADDITIONALLY AND ANASTOMOSED BY HAND. BESIDES, UNSCHEDULED STOMA WAS CREATED. THE PATIENT IS STILL IN THE HOSPITAL, BUT THE PATIENT IS IN STABLE CONDITION. WHEN THE SALES REP CHECKED THE DEVICE, IT WAS FOUND THAT THE FIRING HANDLE COULD NOT BE GRASPED EVEN THOUGH THE ORANGE INDICATOR WAS WITHIN THE GREEN GAP SCALE AND THE SAFETY WAS UNLOCKED POSITION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| O| R