BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 2823156 · Received November 7, 2012

    Report

    Report Number
    3005075853-2012-05059
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 17, 2012
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CARTRIDGE PAN DISLODGED THE ANALYSIS RESULTS FOUND THAT ONE DEVICE WAS RETURNED WITH NO VISUAL NON-CONFORMANCES AND WITH TWO RELOADS PRESENT. RELOAD A WAS RECEIVED FULLY FIRED AND WITH THE PAN DETACHED; RELOAD B WAS RECEIVED UNFIRED. AFTER FURTHER ANALYSIS, IT WAS NOTED THAT A PAN WAS LODGED INSIDE THE CARTRIDGE CHANNEL; THE PAN BELONGED TO THE RETURNED RELOAD A. THE PAN WAS REMOVED FROM THE CHANNEL AND THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH THE RETURNED RELOAD (B). THE DEVICE FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTE TO HAVE THE PROPER B-FORMED SHAPE. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE PAN BECAME DISLODGE FROM THE RELOAD, IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP ASSISTED DISTAL GASTRECTOMY, ECR60D WAS NOT LOADED INTO THE JAWS FOR THE 2ND FIRING. ECR60B WAS USED AT THE 1ST FIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. AFTER THE DEVICE WAS RECEIVED, THE SALES REP FOUND THAT THE CARTRIDGE PAN OF ECR60B WAS BEING LEFT INSIDE THE JAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4C18H

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60B (LOT#: J4C22N) X1, ECR60D (LOT#: J4C159) X1