BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON FLEX 60 POWERED PLUS ENDOPATH STAPLER ARTICULATING ENDOSCOPIC LINEAR CUT

    MDR report key: 16855156 · Received May 2, 2023

    Report

    Report Number
    3005075853-2023-02987
    Event Type
    Injury
    Date Received
    May 2, 2023
    Date of Event
    January 19, 2023
    Report Date
    May 2, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 5/2/2023. D4: BATCH #UNK. THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: A COMPARISON BETWEEN THE DA VINCI XI ENDOWRIST STAPLER AND A CONVENTIONAL LAPAROSCOPIC STAPLER IN RECTAL TRANSECTION: A RANDOMIZED CONTROLLED TRIAL AUTHORS: NAN ZUN TEO / JAMES CHI-YONG NGU CITATION: INT J MED ROBOT. 2023; E2501:1-8. HTTPS://DOI.ORG/10.1002/RCS.2501. THE AIM OF THIS SINGLE CENTRE PROSPECTIVE, PARALLEL GROUP RANDOMIZED CONTROLLED TRIAL WAS TO COMPARE THE OPERATIVE OUTCOMES AND ERGONOMIC DIFFERENCES BETWEEN THE USE OF ROBOTIC STAPLER (RS) AND CONVENTIONAL LAPAROSCOPIC STAPLER (LS) AFTER ROBOTIC RECTAL DISSECTION. BETWEEN MARCH 2018 AND JULY 2022, A TOTAL OF 40 PATIENTS WITH RECTAL CANCER WHO WERE PLANNED FOR ROBOTIC RECTAL SURGERY WERE INCLUDED IN THE STUDY. THESE PATIENTS WERE RANDOMIZED INTO LS (N=20; 11 MALE AND 9 FEMALE; MEDIAN AGE OF 67 (57¿77) YEARS; MEAN BMI OF 23.9 KG/M2) AND RS (N=20; 14 MALE AND 6 FEMALE; MEDIAN AGE OF 64.5 (57¿74.5) YEARS; MEAN BMI OF 24.1 KG/M2). IF THE PATIENT WAS ASSIGNED TO LS, A 45 MM LS (POWERED ECHELON FLEX¿ ENDOPATH®, ETHICON) WAS INTRODUCED EITHER THROUGH THE 12 MM ROBOTIC PORT IN THE RIGHT ILIAC FOSSA OR THE 12 MM SUPRAPUBIC PORT, WHICHEVER WAS MORE ERGONOMIC TO COMPLETE THE RECTAL DIVISION. FOR THE RS GROUP, A 45 MM RS (ENDOWRIST STAPLER, INTUITIVE SURGICAL) WAS INSERTED THROUGH THE 12 MM R3 ROBOTIC PORT AND RECTAL TRANSECTION WAS PERFORMED BY THE LEAD SURGEON USING THE ROBOTIC CONSOLE. REPORTED COMPLICATIONS IN LS GROUP INCLUDE ANASTOMOTIC LEAKS (N=2) AND SEROSAL BLEEDING (N=1). IN CONCLUSION, THE RS REQUIRED LESS ADJUSTMENTS AND RESULTED IN A BETTER USER EXPERIENCE. WHILE THIS COMPLEMENTED THE USE OF ROBOTICS IN RECTAL SURGERY, IT DID NOT RESULT IN A SIGNIFICANT REDUCTION IN THE NUMBER OF STAPLER CARTRIDGES REQUIRED FOR RECTAL TRANSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1533487 ECHELON FLEX 60 POWERED PLUS ENDOPATH STAPLER ARTICULATING ENDOSCOPIC LINEAR CUT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention