BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3883433 · Received June 19, 2014

    Report

    Report Number
    3005075853-2014-04113
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: NICKED KNIFE. THE ANALYSIS FOUND THAT THE LONG60A DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITHOUT A RELOAD PRESENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH A TEST CARTRIDGE RELOAD AND IT FIRED, AND FORMED ALL THE STAPLES AS INTENDED. THE CUT WAS NOTED TO BE JAGGED DUE TO A DAMAGED KNIFE. ONE POSSIBLE CAUSE FOR THIS TYPE OF DAMAGE TO THE KNIFE IS WHEN THE DEVICE IS FIRED OVER AN ALREADY EXISTING STAPLE LINE, HARD OBJECT OR THICKER TISSUE THAN INDICATED. REPEATEDLY FIRING ACROSS EXISTING STAPLE LINES CAN ALSO REDUCE THE ABILITY TO CUT CLEANLY. 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. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, THERE WAS ¿STIFF FIRING¿ OF THE DEVICE. OPENED UP LIKE DEVICE AND FINISHED PROCEDURE SUCCESSFULLY. 30-SECOND DELAY IN PROCEDURE. NO ADVERSE EVENT TO PATIENT. PATIENT DETAILS NOT PROVIDED. USER IS TRAINED AND DEVICE WAS STORED TO LABELING INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361474 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4DG32

    Patients

    Seq Age Sex Outcome Treatment
    1