BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSCOPIC TISSUE APPROXIMATION DEVICE

    MDR report key: 24830827 · Received April 9, 2026

    Report

    Report Number
    3005075853-2026-02673
    Event Type
    Injury
    Date Received
    April 9, 2026
    Date of Event
    December 27, 2025
    Report Date
    April 9, 2026
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    OCW
    PMA / PMN Number
    K940967
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 4/9/2026. D4: BATCH # UNK. D4/G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THEREFORE, (01)GTIN IS NOT AVAILABLE. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. 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: GONG L, YU J, LV ZB, QIN XZ, LI M, GUO W, HUANG B, TIAN YH. REDUCING ANASTOMOTIC COMPLICATIONS WITH ENDOSCOPY IN LAPAROSCOPIC TOTAL GASTRECTOMY. WORLD J GASTROINTEST SURG. 2025 DEC 27;17(12):114079. DOI: 10.4240/WJGS.V17.I12.114079. PMID: 41479718; PMCID: PMC12754292. THE AIM OF THIS STUDY IS TO EXPLORE WHETHER ENDOSCOPIC EXAMINATION COULD REDUCE THE OCCURRENCE OF EARLY POSTOPERATIVE ANASTOMOTIC COMPLICATIONS. BETWEEN JANUARY 2020 TO DECEMBER 2023, A TOTAL OF 160 PATIENTS WHO UNDERWENT LAPAROSCOPIC RADICAL TOTAL GASTRECTOMY WITH ESOPHAGOJEJUNOSTOMY USING CIRCULAR STAPLER RECONSTRUCTION WERE RETROSPECTIVELY ANALYZED. LTG WAS PERFORMED USING FIVE TROCARS. LYMPH NODE DISSECTION WAS CONDUCTED FOLLOWING THE JAPANESE GASTRIC CANCER TREATMENT GUIDELINES (5TH EDITION). THE DUODENUM WAS TRANSECTED USING A LINEAR STAPLER (ECHELON 60, ETHICON ENDO SURGERY), AND THE DUODENAL STUMP WAS SUBSEQUENTLY REINFORCED WITH A PURSE-STRING SUTURE. ROUX-EN-Y RECONSTRUCTION WAS EMPLOYED FOR ESOPHAGOJEJUNOSTOMY. ESOPHAGOJEJUNOSTOMY WAS PERFORMED USING THE HEMIDOUBLE STAPLING TECHNIQUE WITH CIRCULAR STAPLER (ECS 25, ETHICON ENDO-SURGERY). REPORTED COMPLICATIONS ARE LINEAR STAPLER (ECHELON 60, ETHICON ENDO SURGERY) INTRAOPERATIVE -ANASTOMOTIC DEFECTS (N=7) TREATMENT: THREE PATIENTS WITH ANASTOMOTIC DISCONTINUITIES WERE SUBSEQUENTLY TREATED WITH ADDITIONAL SUTURING. -AIR LEAKS (N=3) TREATMENT: NOT PROVIDED -BLEEDING (N=2) TREATMENT: ONE ANASTOMOTIC BLEEDING WAS MANAGED WITH LAPAROSCOPIC SUTURING, AND ANOTHER WAS TREATED WITH ENDOSCOPIC CLIPS DUE TO INTRATHORACIC ANASTOMOSIS. -ANASTOMOTIC STRICTURE (N=1) TREATMENT: ONE PATIENT HAD ANASTOMOTIC STRICTURE, WHICH WAS CORRECTED INTRAOPERATIVELY BY ESOPHAGUS-SPARING ANASTOMOTIC NARROWING REVISION PROCEDURE. -FULL-THICKNESS TEARING (N=1) TREATMENT: NOT PROVIDED POSTOPERATIVE -ANASTOMOTIC LEAKAGE (N=5) TREATMENT: ALL CASES WERE RESOLVED THROUGH CONSERVATIVE MANAGEMENT. -ANASTOMOTIC STRICTURE (N=1) TREATMENT: COMPLETE RESOLUTION WAS ACHIEVED AFTER ENDOSCOPIC DILATION THERAPY. CIRCULAR STAPLER (ECS 25, ETHICON ENDO-SURGERY) INTRAOPERATIVE -ANASTOMOTIC DEFECTS (N=7) TREATMENT: THREE PATIENTS WITH ANASTOMOTIC DISCONTINUITIES WERE SUBSEQUENTLY TREATED WITH ADDITIONAL SUTURING. -AIR LEAKS (N=3) TREATMENT: NOT PROVIDED -BLEEDING (N=2) TREATMENT: ONE ANASTOMOTIC BLEEDING WAS MANAGED WITH LAPAROSCOPIC SUTURING, AND ANOTHER WAS TREATED WITH ENDOSCOPIC CLIPS DUE TO INTRATHORACIC ANASTOMOSIS. -ANASTOMOTIC STRICTURE (N=1) TREATMENT: ONE PATIENT HAD ANASTOMOTIC STRICTURE, WHICH WAS CORRECTED INTRAOPERATIVELY BY ESOPHAGUS-SPARING ANASTOMOTIC NARROWING REVISION PROCEDURE. -FULL-THICKNESS TEARING (N=1) TREATMENT: NOT PROVIDED POSTOPERATIVE -ANASTOMOTIC LEAKAGE (N=5) TREATMENT: ALL CASES WERE RESOLVED THROUGH CONSERVATIVE MANAGEMENT. -ANASTOMOTIC STRICTURE (N=1) TREATMENT: COMPLETE RESOLUTION WAS ACHIEVED AFTER ENDOSCOPIC DILATION THERAPY. IN CONCLUSION, ROUTINE INTRAOPERATIVE ENDOSCOPIC EXAMINATION (IEE) SIGNIFICANTLY REDUCES EARLY ANASTOMOTIC COMPLICATIONS BY ENABLING IMMEDIATE DETECTION AND REPAIR OF TECHNICAL DEFECTS IN ESOPHAGOJEJUNOSTOMY WITH CIRCULAR STAPLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886318 ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention