BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX45

    MDR report key: 2872379 · Received December 13, 2012

    Report

    Report Number
    3005075853-2012-05703
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    October 17, 2012
    Report Date
    December 3, 2012
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE RELOAD LOADED ON THE DEVICE. 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. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE 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. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE?ASKU. WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS? ASKU. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC)? 1ST. IF ECHELON, DURING WHICH STROKE DID THE EVENT OCCUR? FIRING HAD BEEN COMPLETED. WHAT COLOR CARTRIDGE WAS BEING USED?ASKU. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT?NA. WAS BUTTRESSING MATERIAL UTILIZED?NO IF SO, WHICH PRODUCT? WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP?NO. WERE ANY UNEXPECTED NOISES HEARD?NO IF SO, WHEN? 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT THORACOTOMY PROCEDURE, THE DEVICE WAS FIRED AND WHEN THE SURGEON OBSERVED THE STAPLE LINE THE STAPLES WERE MALFORMED AND THE STAPLE LINE WAS INCOMPLETE. THERE WAS NO BLEEDING NOTED. THEY USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX45 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1