BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 LONG ARTICULATING

    MDR report key: 3932342 · Received July 14, 2014

    Report

    Report Number
    3005075853-2014-04924
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS THE PIECE OF METAL THE CARTRIDGE PAN FROM THE CARTRIDGE LEFT IN THE JAWS OF THE DEVICE? NO, IT APPEARED TO BE PART OF THE DEVICE. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? 2ND. WHAT COLOR CARTRIDGE WAS BEING USED? GREEN THE ANALYSIS RESULTS FOUND THAT ONE LONG60A DEVICE WAS RETURNED WITH NO VISUAL NON-CONFORMANCES AND WITH TWO ECR60G CARTRIDGE RELOADS PRESENT. CARTRIDGES (B, C) ECR60G, WERE RETURNED UNFIRED AND IN GOOD VISUAL CONDITION. IN ADDITION, A CARTRIDGE PAN WAS FOUND LODGED INSIDE THE CHANNEL OF CARTRIDGE C. THE PAN WAS REMOVED FROM THE CHANNEL AND THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH THE RETURNED CARTRIDGE RELOADS (B, C). THE DEVICE FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE STAPLE LINES WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE PAN BECAME DISLODGED FROM THE RELOAD (A), IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4). THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SLEEVE PROCEDURE, THE DEVICE COULD NOT BE LOADED AFTER INITIAL FIRING. SMALL PIECES OF METAL WERE VISIBLE IN THE CROTCH OF THE STAPLER. 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
    411275 ECHELON*FLEX60 LONG ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA KADJ31

    Patients

    Seq Age Sex Outcome Treatment
    1