BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON FLEX 60 POWERED PLUS ENDOPATH STAPLER ARTICULATING ENDOSCOPIC LINEAR CUT

    MDR report key: 22787178 · Received August 12, 2025

    Report

    Report Number
    3005075853-2025-06391
    Event Type
    Injury
    Date Received
    August 12, 2025
    Date of Event
    January 1, 2025
    Report Date
    August 12, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 8/12/2025. B3: EXACT EVENT DATE UNK, ENTERED (B)(6) 2025 AS ONLY THE YEAR WAS PROVIDED. D4: BATCH # UNK. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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 DEVICES MENTIONED IN THIS ARTICLE CAUSED/CONTRIBUTED TO THE REPORTED EVENTS IN THE ARTICLE? 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

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: ITO K, KAWAGUCHI Y, ABE S, SEKI Y, MIHARA Y, NISHIOKA Y, ICHIDA A, TAKAMOTO T, AKAMATSU N, HASEGAWA K. TECHNICAL TIPS ON PANCREATOJEJUNOSTOMY AND GASTROJEJUNOSTOMY DURING ROBOTIC PANCREATODUODENECTOMY WITH COMPARISON BETWEEN THE INTERNAL AND EXTERNAL STENT FOR PANCREATOJEJUNOSTOMY. SURG ONCOL. 2025 AUG;61:102239. DOI: 10.1016/J.SURONC.2025.102239. EPUB 2025 MAY 28. PMID: 40460784. THE AIM OF THIS STUDY IS TO PRESENT A CASE OF 203 PATIENTS WHO UNDERWENT PD AT THE UNIVERSITY OF TOKYO FROM JANUARY 2020 TO JULY 2024 WERE INCLUDED IN THIS STUDY. OF THEM, 34 CONSECUTIVE PATIENTS UNDERWENT RPD BETWEEN JANUARY 2023 AND JULY 2024 AND WERE COMPARED WITH 26 PATIENTS UNDERGOING OPD FOR THE SAME INDICATION BETWEEN JANUARY 2020 AND DECEMBER 2022. 5-0, 6-0 PDS II (ETH) WERE USED TO SUTURED AND LIGATED TO PREVENT INTESTINAL MUCOSA, AND THE PANCREATIC DUCT. 4-0 VICRYL (ETH) WAS USED TO SUTURED THE MIDDLE STITCH, AND LASTLY ECHELON FLEX (EES) AND ECHELON PATH (EES) WERE USED FOR STAPLE LINE REINFORCEMENT. REPORTED COMPLAINTS: 5-0, 6-0 PDS II (ETH), 4-0 VICRYL (ETH), ECHELON FLEX (EES) AND ECHELON PATH (EES). FLUID COLLECTION (N=4) TREATMENT: ONE UNDERWENT DRAINAGE UNDER RADIOGRAPHIC INTERVENTION AND THREE PATIENTS FLUID COLLECTION WAS ALLEVIATED WITH DIURETICS. IN CONCLUSION, THE DESCRIBED PJ AND GJ TECHNIQUES AND EVIDENCE-BASED PERIOPERATIVE MANAGEMENT ACHIEVED ZERO CR¿POPF AND DGE IN RPD, SUGGESTING FAVORABLE OUTCOMES. EXTERNAL STENTS MAY NOT IMPROVE RESULTS IN RPD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1378899 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 NA Unknown Required Intervention GST60D