BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUE RELOAD FOR ECHELON

    MDR report key: 3011177 · Received March 19, 2013

    Report

    Report Number
    3005075853-2013-01295
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 22, 2013
    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). INCOMPLETE-INTERRUPTED CYCLE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT DEVICE WAS USED DURING THE PROCEDURE (YOU PROVIDED THE RELOAD CODE ONLY)? .ECR60B/ ECHELON DEVICE'S CODE WAS UNKNOWN. WHERE WAS THE LOCATION OF THE MALFORMED STAPLES DISTAL, PROXIMAL OR IN THE MIDDLE OF THE STAPLE LINE? WHOLE STAPLE LINE. WHERE THE MALFORMED STAPLES ON THE LINE CLOSEST TO THE CUT LINE OR IN ALL OF THE ROWS? UNK. WHEN THE KNIFE MOVED TO THE MIDDLE OF THE STAPLE LINE, ON WHICH STROKE DID THIS OCCUR? . AT THE 1ST STROKE OF THE 2ND FIRING. WHAT COLOR CARTRIDGE WAS BEING USED? BLUE. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? BEFORE: WHITE / AFTER: BLUE. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? YES. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? -- NO. 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? -- NO. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? -- NO. THE ANALYSIS RESULTS SHOWED THAT ONE RELOAD WAS RECEIVED PARTIALLY FIRED 2/3. THE CARTRIDGE RELOAD PARTIALLY FIRED IS CONSISTENT WITH AN INCOMPLETE OR INTERRUPTED CYCLE. THE RETURNED RELOAD WAS RESET AND LOADED INTO A TEST DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION AND ACHIEVED ITS COMPLETE STROKE 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 BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. A SURGICAL PHOTOGRAPH WAS REVIEWED AND IT IS BELIEVED THAT THE COMPLICATION EXPERIENCED WAS MOST PROBABLY AN INTERACTION OF SOME COMBINATION THE FOLLOWING FACTORS: TISSUE THICKNESS TO CARTRIDGE SELECTION MISS MATCH, MIGRANT STAPLE PICKED UP BY THE KNIFE, AND POTENTIALLY IMPROPER DEVICE CLEANING, NOT WAITING THE FULL 15 SECONDS BEFORE FIRING, FIRING TO FAST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRECTOMY, STAPLES WERE NOT DEPLOYED AND THE KNIFE COULD NOT BE MOVED FORWARD AT THE 1ST STROKE OF THE 2ND FIRING. AFTER THE DEVICE CLAMPED THE TARGET TISSUE AGAIN, THE STAPLES WERE FORMED IN LUMBRICOID. THE KNIFE WAS MOVED FORWARD TO THE MIDDLE OF THE STAPLE LINE. ANOTHER CARTRIDGE AND THE SAME ECHELON DEVICE WERE USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. BEFORE THE INCIDENT, THE SAME ECHELON DEVICE WITH ECR60W FOR RESECTION OF THE DUODENUM WAS FIRED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114230 BLUE RELOAD FOR ECHELON STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1