BEUDAMED
    FDA Adverse Event Summary report: N

    ENDOGIA 35 STAPLER

    MDR report key: 1882026 · Received September 28, 2010

    Report

    Report Number
    1882026
    Date Received
    September 28, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 28, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    Report Source
    User Facility report
    Reporter Location
    DC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LAPROSCOPIC ABDOMINAL SURGERY, FOLLWING REMOVAL OF THE APPENDIX, THE DOCTOR WAS HANDED A STAPLER TO SEAL THE CUT END.THE NURSE WAS FAMILIAR WITH THE STAPLER THAT CAME LOADED WITH STAPLES AND ASSUMED SHE WAS HANDING THE DOCTOR THAT ONE, BUT INSTEAD IT WAS A STAPLER THAT DID NOT COME LOADED WITH STAPLES. THE DEVICE CAUSED A VICE LIKE EFFECT AND THERE WAS SIGNIFICANT BLEEDING AROUND THE END BEFORE THE DOCTOR COULD BE GIVEN THE STAPLER WITH STAPLES LOADED TO SEAL THE END.THE SAME MANUFACTURER; ETHICON MAKES BOTH STAPLERS BUT ONE SIZE WITH 35MM STAPLES COMES LOADED AND THE OTHER WITH 45MM STAPLES DOES NOT. THE OR STAFF HAVE BEEN TRAINED ON THEIR USE AND THE DEVICE IS COLOR CODED INDICATING IT IS NOT LOADED, BUT IN A BUSY OR, THIS SEEMS LIKE A MISTAKE JUST WAITING TO HAPPEN. QUESTION; WHY THE MANUFACTURER CANNOT MAKE BOTH STAPLERS COME EITHER LOADED OR NOT LOADED?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOGIA 35 STAPLER STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY, LLC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR