BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 2150634 · Received July 6, 2011

    Report

    Report Number
    3005075853-2011-02768
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 17, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    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 RESULTS SHOWED THAT ONE SC60 DEVICE WAS RETURNED WITH NO VISUAL NON-CONFORMANCES AND WITH A FULLY FIRED RELOAD LOADED ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT ACHIEVED A COMPLETE 3-STROKE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES NOTED. THE DEVICE FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. EVENT COULD NOT BE CONFIRMED AS THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED.

    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 OPEN SURGICAL PROCEDURE OF COLON, THE DEVICE WAS LOCKED OUT AT THE FIRST STROKE OF THE FIRST FIRING. THE JAW COULD NOT BE OPENED WITH THE MANUAL RELEASE LEVER. THEREFORE, THE DEVICE WAS REMOVED BY CUTTING THE TISSUE WITH ANOTHER DEVICE LOADING A BLUE CARTRIDGE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. EVENTUALLY THE JAW WAS OPENED WITH THE MANUAL RELEASE LEVER. ADDITIONAL FOLLOWUP: WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS? ---NO INFORMATION. DURING WHICH STROKE DID THE EVENT OCCUR? ---1ST. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? ---THE DEVICE WAS NOT FIRED BEFORE AND AFTER THIS EVENT. 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 FORCE OF FIRING WAS HIGHER. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? ---NO. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? ---YES, THE DEVICE WAS REMOVED BY CUTTING THE SIDE OF THE JAW WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK NI

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60B