BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 2963394 · Received February 15, 2013

    Report

    Report Number
    3005075853-2013-00637
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 2013
    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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? ON 2ND FIRING. WHAT COLOR CARTRIDGE WAS BEING USED? GREEN (WILL STILL BE IN THE RETURNED DEVICE). WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? NO BUTTRESSING. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? YES IT WAS - IN A WEDGE RESECTION- HOWEVER SURGEON CONSIDERS BY THE 2ND FIRING HE WASN'T CROSSING THE STAPLE LINE. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO. WAS THERE DAMAGE TO THE REMAINING TISSUE? IF YES, HOW WAS THIS RESOLVED? WITH STAPLER JAMMED ON TISSUE, A WIDER WEDGE WAS TAKEN WITH A NEW DEVICE TO TRANSECT OUT THE JAMMED DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH ONE ECR60G CARTRIDGE RELOAD LOADED IN THE DEVICE. THE CARTRIDGE RELOAD WAS RECEIVED FULLY FIRED. IT SHOULD BE NOTED THAT IN ORDER TO OPEN A DEVICE THAT HAS BEING PARTIALLY FIRED OR FULLY FIRED A REVERSE STROKE NEEDS TO BE PERFORMED TRIGGER TO TRIGGER TO HANDLE IN ORDER TO RETURN THE KNIFE TO THE HOME POSITION (INDICATOR IN THE "0" POSITION) AND PRESS THE ANVIL RELEASE BUTTON TO OPEN. 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. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS. EVENT COULD NOT BE CONFIRMED AS THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED AND THE KNIFE WORKED AS INTENDED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A WEDGE RESECTION PROCEDURE, THE STAPLER WAS PLACED AND CLOSED ON THE LUNG, THE SURGEON ADVANCED THE BLADE THROUGH THE FIRST CLICK, ON THE SECOND IT JAMMED - HE COULD NOT ADVANCE THE BLADE FURTHER. HE PUT THE STAPLER INTO REVERSE AND TRIED PULLING THE TRIGGER BACK THROUGH THE REST OF THE BLADE AND THE BLADE WOULD NOT REVERSE. OPENED UP A NEW STAPLER WITH A NEW CARTRIDGE AND USED THE NEW STAPLER TO TRANSECT OUT THE JAMMED ONE. SURGERY WAS PROLONGED FIFTEEN MINUTES. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66960 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4CN2L

    Patients

    Seq Age Sex Outcome Treatment
    1