BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 4202277 · Received October 27, 2014

    Report

    Report Number
    3005075853-2014-07365
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 6, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS FOUND THAT ONE PSE60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE LOADED ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. EVENT COULD NOT BE CONFIRMED AS NO INCOMPLETE STAPLE LINE WAS NOTED DURING FUNCTIONAL TESTING. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ON FURTHER CONVERSATION WITH THE SURGEONS HERE IS MORE INFORMATION: REVISION CASE, PROLAPSED BAND TO GASTRIC SLEEVE. THE STAPLER FULLY FIRED BUT STAPLES WERE NOT FORMED ON THE 2 INNER ROWS CLOSEST TO THE CUT LINE ON THE PATIENT SIDE. ON WHAT SIDE WAS THE MISSING ROW OF STAPLES (PATIENT SIDE OR REMNANT SIDE)? PATIENT SIDE. HOW MUCH BLOOD WAS LOSS (ML)? UNKNOWN. DID THE PATIENT REQUIRE A BLOOD TRANSFUSION? NO. IF THE PATIENT RECEIVED BLOOD, HOW MANY UNITS WERE GIVEN? NOT NECESSARY. IS THE PATIENT MALE OR FEMALE? FEMALE. WHAT IS THE PATIENT S BMI? (B)(6). WAS BUTTRESSING MATERIAL USED ON ALL FIRINGS? IF NO, WHICH FIRINGS WERE DONE USING BUTTRESSING? BUTTRESSING ON ALL FIRINGS. WHAT COLOR CARTRIDGES WERE USED TO FINISH THE CASE? GREEN. ARE THERE PHOTOS AVAILABLE? NO. DID THE POST-OPERATIVE CARE CHANGE BASED ON THE EVENT? NO. WHAT IS THE CURRENT STATUS OF THE PATIENT? DOING WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY, ON THE THIRD FIRING USING A GREEN RELOAD AND GORE® BUTTRESSING MATERIAL THE STAPLER FULLY CUT AND ONE ROW OF STAPLES WERE NOT DEPLOYED. IT IS UNKNOWN IF THIS WAS ON THE PATIENT SIDE OR THE REMNANT SIDE. THERE WAS BLEEDING, BUT THE AMOUNT IS UNKNOWN. IT IS UNKNOWN IF THE PATIENT RECEIVED A BLOOD TRANSFUSION. THE SURGEON OVER-SEWED THE AREA TO CONTROL THE BLEEDING. A SECOND DEVICE WAS OPENED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES. THE COLOR CARTRIDGE THAT WAS USED FOR THE FIRST AND SECOND FIRINGS WAS GREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682089 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - ECR60G