BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60 ENDOPATH STAPLER

    MDR report key: 4963101 · Received August 4, 2015

    Report

    Report Number
    3005075853-2015-04929
    Event Type
    Malfunction
    Date Received
    August 4, 2015
    Date of Event
    July 16, 2015
    Report Date
    July 17, 2015
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # L54M2A. THE ANALYSIS RESULTS SHOWED THAT ONE EC60 DEVICE WAS RETURNED WITH NO VISUAL NON-CONFORMANCES AND WITH SEVEN CARTRIDGE RELOADS PRESENT. CARTRIDGE (B, C) ECR60B, L5555P WERE RECEIVED FULLY FIRED AND IN GOOD VISUAL CONDITION. CARTRIDGE (D) ECR60B, M5294F WAS RECEIVED FULLY FIRED AND IN GOOD VISUAL CONDITION. CARTRIDGE (E) ECR60B, M5294F WAS RECEIVED FULLY FIRED AND WITH CARTRIDGE DECK DAMAGE. THE DAMAGE TO THE CARTRIDGE IS CONSISTENT WITH THE DEVICE BEING CLAMPED OVER A HARD OBJECT. WHEN THIS HAPPENS THE CARTRIDGE GETS INDENTED THEREFORE THERE IS NOT ENOUGH SPACE FOR THE SLED PUSHING THE DRIVER TO CONTINUE ITS RUN, THIS IS THE RESULT OF MALFORMED STAPLES. CARTRIDGE (F, G) ECR60W, M52U3U WERE RECEIVED FULLY FIRED AND IN GOOD VISUAL CONDITION. CARTRIDGE (H) ECR60W, L55J5L WAS RECEIVED FULLY FIRED AND IN GOOD VISUAL CONDITION. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD 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. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC DISTAL GASTRECTOMY, THE FIRING FORCE WAS HIGHER THAN EXPECTED AT THE THIRD STROKE OF THE SIXTH FIRING ON THE STOMACH. THEN, IT WAS FOUND THAT DEPLOYED STAPLES OF THE DISTAL END WERE MALFORMED. THE CARTRIDGE WAS BLUE. ADDITIONALLY, BURIED SUTURE WAS PERFORMED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508717 ECHELON 60 ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1