BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*ILS CURVED CIR STAPL

    MDR report key: 1760231 · Received July 16, 2010

    Report

    Report Number
    3005075853-2010-04003
    Event Type
    Injury
    Date Received
    July 16, 2010
    Date of Event
    June 22, 2010
    Report Date
    June 23, 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
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4). (DEVICE B): OTHER # = F5WK1G (BATCH #); EXP DATE = 08/29/2014. (DEVICE B): 9/29/2009. WASHER UNCUT. DEVICES A AND B ARRIVED IN GOOD VISUAL CONDITION WITHOUT STAPLES PRESENT AND WITH THE BREAKAWAY WASHERS UNCUT AND INDENTED, INDICATING THAT THE DEVICES 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. FOR MORE INFORMATION PLEASE REFER TO THE INSTRUCTIONS FOR USE. THE DEVICES WERE RELOADED WITH STAPLES AND TESTED FOR FUNCTIONALITY WITH TEST WASHERS; THE DEVICES FORMED ALL THE STAPLES, AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHERS WITHOUT INCIDENT. THE STAPLE LINES WERE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THE PATIENT RECEIVED A STOMA INSTEAD OF AN ANASTOMOSIS DUE TO TWO MISFIRES WITH THE DEVICES. AFTER THE FIRST FIRING ACROSS A TA45-STAPLELINE WITHOUT ANY OTHER MATERIAL E.G. BUTTRESSING, THE DEVICE FORMED STAPLES BUT LEFT THE TISSUE WITH A HOLE. THE SURGEON SAW THIS WITH HIS BARE EYE AND THEN MANAGED TO FREE ENOUGH BOWEL TO CREATE A NEW ANASTOMOSIS. THIS TIME THE STAPLES WERE MALFORMED AND NOW THERE WAS NOT ENOUGH BOWEL LEFT TO CREATE A NEW ANASTOMOSIS. INSTEAD HE HAD TO CREATE A STOMA.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R