BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSCOPIC LNR CUTR (EXACT CODE UNKNOWN)

    MDR report key: 22237212 · Received June 17, 2025

    Report

    Report Number
    3005075853-2025-04563
    Event Type
    Injury
    Date Received
    June 17, 2025
    Date of Event
    January 15, 2014
    Report Date
    June 17, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    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: 6/17/2025. 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 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: HOSOGI H, YOSHIMURA F, YAMAURA T, SATOH S, UYAMA I, KANAYA S. ESOPHAGOGASTRIC TUBE RECONSTRUCTION WITH STAPLED PSEUDO-FORNIX IN LAPAROSCOPIC PROXIMAL GASTRECTOMY: A NOVEL TECHNIQUE PROPOSED FOR SIEWERT TYPE II TUMORS. LANGENBECKS ARCH SURG. 2014 APR;399(4):517-23. DOI: 10.1007/S00423-014-1163-0. EPUB 2014 JAN 15. PMID: 24424495. THIS STUDY AIMS TO DESCRIBE A NOVEL TECHNIQUE OF ESOPHAGOGASTRIC TUBE RECONSTRUCTION WITH STAPLED PSEUDO-FORNIX IN LPG FOR SIEWERT TYPE II AEG AND ALSO DISCUSSES THE INDICATION FOR THIS PROCEDURE FROM THE ONCOLOGICAL VIEWPOINT. BETWEEN 2010 TO FEBRUARY 2013, A TOTAL OF 15 PATIENTS UNDERWENT LAPAROSCOPIC PROXIMAL GASTRECTOMY (LPG) WITH GASTRIC TUBE RECONSTRUCTION WHILE USING ETS-FLEX 45 NO-KNIFE (ETHICON ENDO-SURGERY, TOKYO, JAPAN) WHICH WAS APPLIED BETWEEN THE LEFT DORSAL SIDE OF THE ESOPHAGUS AND THE ANTERIOR WALL OF THE GASTRIC TUBE GUIDED BY A NASOGASTRIC TUBE, THROUGH THE LEFT LOWER TROCAR. REPORTED COMPLICATIONS ARE: ETS-FLEX 45 NO-KNIFE (ETHICON ENDO-SURGERY, TOKYO, JAPAN). N=1 (MALE, AGE=72). GRADE IIIA ANASTOMOTIC LEAK. TREATMENT: TREATED CONSERVATIVELY WITH THORACIC DRAINAGE. N=1 (MALE, AGE=57). GRADE II WOUND INFECTION. TREATMENT: LAPAROSCOPIC HEMATOMA REMOVAL. GRADE IIIA ANASTOMOTIC STENOSIS. TREATMENT: ENDOSCOPIC BALLOON DILATATION. N=1 (MALE, AGE=78). GRADE II PNEUMONIA. TREATMENT: NOT REPORTED. N=1 (MALE, AGE=66). GRADE IIA ANASTOMOTIC STENOSIS. TREATMENT: ENDOSCOPIC BALLOON DILATATION. N=1 (MALE, AGE=75). GRADE IIIA ANASTOMOTIC STENOSIS. TREATMENT: ENDOSCOPIC BALLOON DILATATION. IN CONCLUSION, OUR NEW TECHNIQUE OF ESOPHAGOGASTRIC TUBE RECONSTRUCTION WITH STAPLED FUNDOPLICATION IN LPG WAS SIMPLE AND FEASIBLE. ALTHOUGH LONG-TERM FOLLOW-UP AND A LARGER NUMBER OF PATIENTS ARE REQUIRED TO EVALUATE LONG-TERM FUNCTIONAL OUTCOMES AND THE ONCOLOGICAL ADEQUACY OF OUR NEW TECHNIQUE, IT HAS THE POTENTIAL TO BE THE PROCEDURE OF CHOICE IN LPG, ESPECIALLY FOR PATIENTS WITH EARLY-STAGE TYPE II AEG AND/OR FOR SOME SELECTED HIGH-RISK PATIENTS WHO NEED TUMOR RESECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37338 ENDOSCOPIC LNR CUTR (EXACT CODE UNKNOWN) STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention