BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60 ENDOPATH STAPLER

    MDR report key: 1820746 · Received September 20, 2007

    Report

    Report Number
    1527736-2007-06260
    Event Type
    Malfunction
    Date Received
    September 20, 2007
    Date of Event
    August 23, 2007
    Report Date
    August 24, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT ONE DEVICE WAS RETURNED WITH NO VISUAL NON-CONFORMANCE AND WITH NO CARTRIDGE PRESENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE AND IT ACHIEVED A COMPLETE 3-STROKES FIRE WITHOUT ANY DIFFICULTIES NOTED. THE DEVICE FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE CARTRIDGE WAS PLACED ON THE DEVICE WITHOUT ANY DIFFICULTIES AND DID NOT FALL OUT. IT SHOULD BE NOTED THAT ALL INSTRUMENTS ARE INSPECTED 100% FOR STAPLE PRESENCE BY A VISUAL SYSTEM PRIOR TO THE PLACEMENT OF THE STAPLER RETAINER. IN ADDITION, AT FINISHED GOODS THE INSTRUMENTS ARE VISUALLY INSPECTED BASED ON A SAMPLE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THE DEVICE FIRED AN INCOMPLETE STAPLE LINE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 ENDOPATH STAPLER GDW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1