BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    75MM SELECTABLE NEW TLC

    MDR report key: 2163118 · Received July 15, 2011

    Report

    Report Number
    3005075853-2011-02899
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K092577
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? STOMACH. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC)? 1ST. WHAT COLOR (BLUE/GOLD/GREEN) WAS SELECTED ON THE SELECTABLE STAPLE HEIGHT SELECTOR BEFORE FIRING? GREEN. WAS THE CARTRIDGE LOADED WITH THE RETAINING CAP ON? YES. DID THE SURGEON MOVE THE FIRING KNOB LEFT AND RIGHT BEFORE FIRING? NO. WAS THE HANDLE CLOSED COMPLETELY BEFORE FIRING? YES. WAS BUTTRESSING MATERIAL UTILIZED? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. WERE ANY UNEXPECTED NOISES HEARD? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? NO. 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. TISSUE SAMPLE RETURNED (X RAY ATTACHED) AND REVIEWED BY EES FIELD QUALITY ENGINEER: THERE APPEARED TO BE AN ALIGNMENT ISSUE. THE ISSUE OCCURRED APPROXIMATELY FIVE STAPLES FROM THE PROXIMAL OR CROTCH AREA. BASED ON THE FACT THAT THREE STAPLES HAD ONE LEG THAT MISSED THE ANVIL AND THE FACT THEY ARE PROGRESSIVELY GETTING BENT MORE BACK TOWARD THE DEVICE, IT IS MY OPINION THAT THERE MAY HAVE BEEN SOME DENSE TISSUE IN THIS AREA AND AS THE KNIFE MOVED FORWARD, THE TISSUE MOVED FORWARD AND ROTATED OUTWARD SIMULTANEOUSLY. THE ROTATION THEORY IS BECAUSE ONLY ONE LEG MISSED THE ANVIL AND A STAPLE IN THE SECOND ROW JUMPED TO A STAPLE POCKET THAT IT WAS NOT SUPPOSED TO HIT. YOU CAN SEE THIS BECAUSE THE STAPLES' LEG IS BENT IN THE OPPOSITE DIRECTION IT SHOULD BE BENDING AND IN OPPOSITION TO THE LEGS THAT MISSED THE ANVIL. IT IS MY OPINION THAT TISSUE MOVEMENT CREATED A MINOR STAPLE LEG TO ANVIL POCKET MISALIGNMENT. ADDITIONAL INFORMATION: 1ST FIRING, BLUE SETTING, SMALL BOWEL AND THIS IS WHERE THE STAPLE MISFIRED. 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 WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER SHAPE. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DIFFICULTIES NOTED AND NO CARTRIDGE WAS RETURNED FOR ANALYSIS. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A WHIPPLE PROCEDURE, THE MIDDLE THIRD OF THE STAPLE LINE DID NOT FORM PROPERLY ON THE STOMACH. A NEW DEVICE WAS USED TO COMPLETE. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 75MM SELECTABLE NEW TLC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA H43M3E

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD = SR75