BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH

    MDR report key: 24765487 · Received April 2, 2026

    Report

    Report Number
    3005075853-2026-02455
    Event Type
    Injury
    Date Received
    April 2, 2026
    Date of Event
    October 27, 2025
    Report Date
    April 9, 2026
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 4/2/2026. D4: BATCH # UNK. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY 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 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.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 4/9/2026. CORRECTED DATA: B1, B2, H1. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. WE DO NOT THINK THAT ANY OF THE COMPLICATIONS WERE RELATED TO THE STAPLER. UPON REVIEW OF THE INFORMATION PROVIDED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT AND IS BEING CONSIDERED NOT REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE: THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: GRINLINTON ME, PATEL P, NAIR A, CLARKE M, PLANK L, MURPHY R, BOOTH M. TEN-YEAR RESULTS OF A RANDOMIZED TRIAL COMPARING BANDED ROUX-EN-Y GASTRIC BYPASS TO SLEEVE GASTRECTOMY FOR TYPE 2 DIABETES AND WEIGHT LOSS. OBES SURG. 2025 DEC;35(12):4949-4958. DOI: 10.1007/S11695-025-08349-8. EPUB 2025 OCT 27. PMID: 41144146. THE AIM OF THIS STUDY IS TO UNDERGO FURTHER RESEARCH COMPARIN GLAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS (LRYGB) AND LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG) ARE COMMON BARIATRIC PROCEDURES THAT ARE EFFECTIVE IN TREATING TYPE 2 DIABETES (T2D) IN PATIENTS WITH OBESITY. , AS THIS QUESTION HAS NOT BEEN ANSWERED BY THE TRIAL. FROM SEPTEMBER 2011 TO OCTOBER 2014, A TOTAL OF 114 PATIENTS WERE RANDOMISED AT THE TIME OF SURGERY; 56 TO SR LRYGB AND 58 TO LSG. ECHELON FLEX (EES) WAS USED IN GASTRIC RESECTION ALONGSIDE A 36-FRENCH OROGASTRIC BOUGIE, COMMENCING 2 CM PROXIMAL FROM THE PYLORUS. REPORTED COMPLICATIONS: ECHELON FLEX (EES). LSG GROUP (N=53). SYMPTOMATIC CHOLELITHIASIS (N=6). TREATMENT: NOT REPORTED. STRICTURE/STENOSIS REQUIRING DILATATION (N=5). TREATMENT: NOT REPORTED. DYSPHAGIA (N=1). TREATMENT: REQUIRING TO CHANGE OF SILASTIC RING (SR). REFLUX (N=7). TREATMENT: ONLY 1 PATIENT REQUIRED A CONVERSION TO SR-LRYGB AND THIS PATIENT ALSO WENT ON TO HAVE THEIR SILASTIC RING REMOVED FOR DYSPHAGIA. PERSISTENT/RECURRENT TYPE 2 DIABETES (N=1). TREATMENT: NOT REPORTED. IN CONCLUSION, SR-LRYGB REMAINS SUPERIOR TO LSG FOR DIABETES REMISSION AND WEIGHT LOSS AT 10 YEARS FOLLOWING SURGERY. THIS STUDY CONFIRMS LONG-TERM ENHANCED PATIENT OUTCOMES IN PATIENTS UNDERGOING SR-LRYGB WHEN COMPARED DIRECTLY WITH LSG. THIS STUDY ADDS TO THE MOUNTING BODY OF EVIDENCE THAT DEMONSTRATES SUSTAINED DIABETES REMISSION AND WEIGHT LOSS IN PATIENTS UNDERGOING SR-LRYGB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831225 ECHELON ENDOPATH STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention