BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PWRD 25MM CURVED CIRCULAR, 18CM SHAFT

    MDR report key: 24137099 · Received January 21, 2026

    Report

    Report Number
    3005075853-2026-00640
    Event Type
    Injury
    Date Received
    January 21, 2026
    Date of Event
    December 22, 2025
    Report Date
    March 23, 2026
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036015369
    PMA / PMN Number
    K163523
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 3/23/2026. CORRECTED DATA: H6 (HEALTH EFFECT - CLINICAL CODE).

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 1/21/2026 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. 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. 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: SAITO A, OTSUKA K, GOTO S, ARIYOSHI T, YAMASHITA T, MOTEGI K, KOMOTO M, KISHIMOTO Y, MURAKAMI M, AOKI T. COMPARISON OF ANASTOMOTIC STRICTURE RATES BETWEEN 23- AND 25-MM POWERED CIRCULAR STAPLERS IN CERVICAL ESOPHAGOGASTRIC ANASTOMOSIS: A PROPENSITY-MATCHED STUDY. ESOPHAGUS. 2025 DEC 22. DOI: 10.1007/S10388-025-01171-2. EPUB AHEAD OF PRINT. THIS STUDY AIMED TO COMPARE STENOSIS RATES BETWEEN NEWLY INTRODUCED 23- AND 25-MM POWERED CIRCULAR STAPLER (CSS) IN CERVICAL ESOPHAGOGASTRIC ANASTOMOSIS. FROM (B)(6) 2022 TO (B)(6) 2024, 126 PATIENTS WHO UNDERWENT THORACOSCOPIC MCKEOWN ESOPHAGECTOMY WITH RETROSTERNAL GASTRIC CONDUIT RECONSTRUCTION WERE RETROSPECTIVELY ANALYZED. THEY WERE CATEGORIZED INTO THE 23 MM (N = 52) AND 25-MM (N = 74) CS GROUPS. REPORTED COMPLICATIONS INCLUDE THE INCIDENCE OF ANASTOMOTIC STRICTURE WAS 18.0% (7 CASES) AND 12.8% (5 CASES) IN THE 23- AND 25-MM CS GROUPS, RESPECTIVELY. THE INCIDENCE OF ANASTOMOTIC LEAKAGE AND THE LEAKAGE LOCATION REVEALED NO SIGNIFICANT DIFFERENCES BETWEEN THE TWO GROUPS. IN CONCLUSION, 23- AND 25-MM POWERED CSS ACHIEVED COMPARABLE ANASTOMOTIC STRICTURE RATES IN CERVICAL ESOPHAGOGASTRIC ANASTOMOSIS DURING MCKEOWN ESOPHAGECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197529 PWRD 25MM CURVED CIRCULAR, 18CM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036015369

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other