BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3951134 · Received July 22, 2014

    Report

    Report Number
    3005075853-2014-05158
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 11, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS FOUND THAT ONE PLE60A DEVICE (B) WAS RETURNED WITH THE ANVIL BENT UPWARDS AND WITH AN ECR60G LOADED IN THE DEVICE. ADDITIONALLY, THE RELOAD WAS RECEIVED WITH THE RIGHT SIDE FULLY FIRED, LEFT SIDE OUTER ROW FULLY FIRED, AND THE TWO INNER ROWS THIRD AND FOUR DOUBLE DRIVER DID NOT DEPLOY THE STAPLES. UPON EVALUATION OF THE RELOAD, THE CARTRIDGE BODY, ONE PIECE SLED AND SOME DRIVERS WERE NOTED TO BE DAMAGED. NO OBVIOUS DAMAGE TO THE CARTRIDGE DECK WAS NOTED, WHICH SUGGESTS THE CARTRIDGE, MAY NOT HAVE BEEN FIRED OVER A HARD OBJECT. IT IS POSSIBLE THAT THE DEVICE WAS CLAMPED OVER AN EXCESS OF TISSUE CAUSING THE ANVIL TO BENT AND FOR THE FIRING STROKE AND THE STAPLE FORM TO BE INCOMPLETE. THE DEVICE WAS NOT TESTED FOR FUNCTIONALITY DUE TO THE CONDITION OF THE ANVIL, HOWEVER THE DEVICE WAS DRY FIRED TO TEST THE CONDITION OF THE FIRING MECHANISM AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY, THE DEVICE WAS FIRED WITH A GREEN CARTRIDGE AND IT MISFIRED. THERE WAS A CARTRIDGE FRACTURE. ON THE SLEEVE SIDE (PATIENT SIDE) THE OUTER ROW OF STAPLES WAS FINE. THE INNER TWO ROWS HAD STAPLES BUT THEY WERE MALFORMED; THE LEGS WERE STRAIGHT. ANOTHER DEVICE WAS OPENED AND THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCES. THE PATIENT¿S SEX AND BMI IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427981 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1