BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 2803248 · Received October 24, 2012

    Report

    Report Number
    3005075853-2012-04853
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 5, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH ONE ECR60W CARTRIDGE RELOAD LOADED IN THE DEVICE. THE CARTRIDGE RELOAD WAS RECEIVED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE KNIFE RETURN WORKED AS INTENDED, AND THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS?---NO INFORMATION. WHAT COLOR CARTRIDGE WAS BEING USED? ---WHITE. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? ---NO INFORMATION. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? ---NO INFORMATION. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? ---NO INFORMATION. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? ---NO INFORMATION. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? ---THE OPENING FORCE WAS HIGHER. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? ---YES. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? ---THE DEVICE WAS REMOVED BY PRESSING THE RELEASE BUTTON SEVERAL TIMES. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? ---NO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP ASSISTED DISTAL GASTRECTOMY, THE FIRING TRIGGER COULD NOT BE GRASPED AT THE FIRST STROKE OF THE SIXTH FIRING WHEN THE DEVICE WAS USED ON THE JEJUNUM. THE CARTRIDGE WAS WHITE. THE JAWS COULD NOT BE RELEASED WITH THE MANUAL KNIFE REVERSE SWITCH SOON. AFTER THE REVERSE BUTTON WAS PRESSED SEVERAL TIMES, THE JAWS COULD BE RELEASED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE DOCTOR COMMENTED THAT THE INCIDENT MIGHT HAVE OCCURRED AS THE JAWS HAD NOT BEEN CLEANED WELL PRIOR TO THE FIRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1