BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 2022363 · Received March 17, 2011

    Report

    Report Number
    3005075853-2011-01063
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 24, 2011
    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). UNCUT WASHER BLEMISHED. THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION WITHOUT STAPLES PRESENT AND WITH THE BREAKAWAY WASHER UNCUT AND INDENTED, 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 BEFORE FIRING THE DEVICE, THE ORANGE INDICATOR SHOULD BE FULLY WITHIN THE GREEN RANGE OF THE GAP SETTING SCALE. IN ADDITION, IT SHOULD BE NOTED THAT IF THE FIRING SEQUENCE IS NOT COMPLETE (PLASTIC TO PLASTIC), STAPLES COULD BE PARTIALLY DEPLOYED WITHOUT CUTTING THE WASHER. FOR MORE INFORMATION, PLEASE REFER TO THE INSTRUCTIONS FOR USE. THE DEVICE WAS RELOADED WITH STAPLES AND TESTED FOR FUNCTIONALITY WITH A TEST WASHER; 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 AN ANASTOMOSIS PROCEDURE BETWEEN THE ESOPHAGUS AND THE JEJUNUM, THE SOUND OF PUNCHING OUT THE WASHER WAS NOT HEARD WHEN THE SURGEON GRASPED THE FIRING HANDLE AS MUCH AS POSSIBLE. AFTER THAT, THE ADJUSTING KNOB WAS HALF ROTATED AND THE DEVICE WAS RELEASED. IT WAS CONFIRMED THAT THE DONUT WAS FORMED PROPERLY, BUT THE TARGET TISSUE WAS NOT ANASTOMOSED AS INTENDED. THEREFORE THE TARGET TISSUE WAS ANASTOMOSED AGAIN AT THE ORAL ASIDE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE. THE SURGEON COMMENTED THAT THE ABDOMINAL ESOPHAGUS HAD BEEN FIRED AT THE BEGINNING, SO IT HAD BEEN DIFFICULT TO ANASTOMOS THE TISSUE AGAIN.

    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 G4TV19

    Patients

    Seq Age Sex Outcome Treatment
    1