BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREEN RELOAD

    MDR report key: 1904558 · Received November 22, 2010

    Report

    Report Number
    3005075853-2010-06633
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CARTRIDGE DRIVERS. THE ANALYSIS RESULTS FOUND THAT ONE (B)(4) RELOAD WAS RECEIVED UNFIRED AND WITH ONE DRIVER OUTSIDE THE POCKETS CONTAINED BETWEEN THE PAN AND RELOAD. THE RETURNED CARTRIDGE RELOAD WAS TESTED FOR FUNCTIONALITY BY RESETTING AND LOADING IT INTO A TEST DEVICE. THE RELOAD WAS LOADED WITHOUT ANY DIFFICULTIES NOTED. THE FUNCTIONAL TEST DEMONSTRATED THAT THE REMAINING STAPLES IN THE CARTRIDGE RELOAD FORMED PROPERLY AND THE INSTRUMENT ACHIEVED ITS COMPLETE 3-STROKE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. HOWEVER, SOME STAPLES WERE MISSING ALONG THE STAPLE LINE. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE AND DRIVERS 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. EVENT COULD NOT BE CONFIRMED AS NO DEVICE WAS RECEIVED FOR ANALYSIS. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT II ELECTROSURGICAL UNIT WAS USED DURING A PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE PUMP FAILED TO PUMP WITH SUFFICIENT FLOW AND PRESSURE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SIGMOIDECTOMY PROCEDURE, AT FIRST, THE DEVICE HAD A LITTLE DIFFICULTY IN BEING LOADED INTO THE JAW FOR THE SECOND FIRING. THE FIRING TRIGGER COULD NOT BE GRASPED. WHEN THE CARTRIDGE WAS REMOVED FROM THE JAW, IT WAS FOUND THAT THE STAPLE DRIVER WAS BROKEN. WHEN THE OTHER NEW CARTRIDGE WAS LOADED INTO THE SAME INSTRUMENT AND FIRED, THE FIRING WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREEN RELOAD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1