BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3962022 · Received July 28, 2014

    Report

    Report Number
    3005075853-2014-05282
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 10, 2014
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING NUMBER: (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WILL THE DEVICE BE RETURNED WITH A TROCAR ATTACHED? IF YES, PLEASE PROVIDE THE MANUFACTURER AND PRODUCT CODE OF THE TROCAR. YES. I HAVE ALREADY RETURNED THE DEVICE. I BELIEVE IT WAS A B12LT OR A CB12LT. DID THE DEVICE DELIVER A COMPLETE STAPLE AND CUT LINE? YES. WAS THERE DIFFICULTY OPENING THE DEVICE? YES. IT WOULD NOT OPEN. HOW WAS THE DEVICE REMOVED FROM THE TISSUE? BECAUSE IT WAS A COMPLETE STAPLE LINE, IT WAS EASY TO REMOVE. IT COULD NOT BE OPENED. DID THE JAWS OF THE DEVICE OPEN AFTER FIRING? NOT AFTER THE LAST FIRING. WHAT COLOR CARTRIDGE WAS BEING USED? I BELIEVE IT WAS GREEN.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS FOUND THAT ONE LONG60A DEVICE WAS RETURNED INSERTED THROUGH A B12LT TROCAR AND WITH THE CLOSING TRIGGER AND ANVIL IN THE CLOSED POSITION. FURTHERMORE, THE FIRING MECHANISM IN THE RETURN STROKE WITH THE KNIFE NOT FULLY BACK. ONE ECR60B CARTRIDGE RELOAD WAS LOADED IN THE DEVICE. THE CARTRIDGE RELOAD WAS RECEIVED FULLY FIRED AND IN GOOD VISUAL CONDITION. IN ADDITION, A CLIP WAS FOUND LODGED BEHIND THE KNIFE, RESULTING IN THE FIRING MECHANISMS JAMMING. TO MITIGATE THE POTENTIAL FOR STAPLES GETTING INTO THE CARTRIDGE AND INTERFERING WITH THE KNIFE PATH DURING DEVICE FIRING, PRIOR TO RELOADING THE DEVICE, RINSE THE ANVIL AND CARTRIDGE JAW IN STERILE SOLUTION AND THEN WIPE THE ANVIL AND CARTRIDGE JAW TO CLEAN ANY FORMED BUT UNUSED STAPLES FROM THE DEVICE. ADDITIONALLY, PROPER CARE SHOULD BE TAKEN WHEN PLACING THE DEVICE ON THE TISSUE TO BE STAPLED, TO ENSURE THAT NO HARD OBSTRUCTION SUCH AS A CLIP IS INCLUDED WITH THE TISSUE INSIDE THE JAWS. FIRING THE DEVICE WITH A CLIP IN THE JAWS CAN JAM THE FIRING MECHANISM RESULTING IN THE DEVICE NOT OPENED. NO FURTHER FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC SLEEVE PROCEDURE, THE DEVICE LOCKED AFTER THE COMPLETION OF THE THIRD FIRING SEQUENCE. THE STAPLE LINE WAS COMPLETE; BUT THE DEVICE COULD NOT BE DE-ARTICULATED. HAD TO TAKE OUT OF THE PATIENT WITH THE TROCAR. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437443 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4EG83

    Patients

    Seq Age Sex Outcome Treatment
    1