BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 24208231 · Received January 29, 2026

    Report

    Report Number
    3005075853-2026-00860
    Event Type
    Injury
    Date Received
    January 29, 2026
    Date of Event
    May 6, 2025
    Report Date
    January 29, 2026
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 1/29/2026. E1: (B)(6). 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.

    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: SANTULLO F, DE CICCO NARDONE A, EL HALABIEH MA, LODOLI C, ABATINI C, FERRACCI F, CAMPOLO F, BENVENGA G, SCAMBIA G, PACELLI F, IANIERI MM. TOTALLY INTRACORPOREAL COLORECTAL ANASTOMOSIS (TICA) AFTER SEGMENTAL COLORECTAL RESECTION FOR DEEP ENDOMETRIOSIS: TECHNICAL NOTES AND CASE SERIES. ARCH GYNECOL OBSTET. 2025 AUG;312(2):555-561. DOI: 10.1007/S00404-025-08040-4. EPUB 2025 MAY 6. PMID: 40327066; PMCID: PMC12334526. THE AIM OF THIS STUDY WAS TO EVALUATE THE SAFETY AND FEASIBILITY OF TOTALLY INTRACORPOREAL COLORECTAL ANASTOMOSIS (TICA) IN PATIENTS UNDERGOING COLORECTAL RESECTION FOR THE TREATMENT OF DEEP ENDOMETRIOSIS (DE) AFFECTING THE BOWEL. BETWEEN JANUARY 2021 AND AUGUST 2024, 33 CONSECUTIVE PATIENTS WITH DE TREATED WITH SEGMENTAL COLORECTAL RESECTION WERE ENROLLED. ECHELON FLEX (EES) AND ENDOPATH STAPLERS (EES) WERE USED TO CARRIED OUT UNTIL REACHING THE RECTAL WALL BELOW THE ENDOMETRIOTIC NODULE, AND THEN THE RECTUM WAS TRANSECTED WITH A LINEAR STAPLER. VICRYL (ETH) WAS USED TO BOUND AT THE HOLE OF THE TIP. REPORTED COMPLICATION: ECHELON FLEX (EES) ENDOPATH STAPLERS (EES) 0 VICRYL (ETH) POSTOPERATIVE BLEEDING OF THE ANASTOMOSIS (N=2) TREATMENT: NOT REPORTED POSTOPERATIVE ILEUS (N=1) TREATMENT: MEDICALLY TREATED IN CONCLUSIONS, THE STUDY SHOWS THAT TICA IS A SAFE AND FEASIBLE TECHNIQUE IN PATIENTS WHO UNDERGO LAPAROSCOPIC COLORECTAL RESECTION FOR DE. FURTHER STUDIES ARE STILL REQUIRED TO EVALUATE A POSSIBLE IMPROVEMENT IN FUNCTIONAL OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272715 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention