BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 22371343 · Received July 1, 2025

    Report

    Report Number
    3005075853-2025-04935
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    January 1, 2018
    Report Date
    July 1, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    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: 7/1/2025 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 BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF PUBLISHED SCIENTIFIC ARTICLES CAPTURED UNDER CAPA-014204 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

    TITLE: CLINICAL OUTCOMES OF LOCKING COMPRESSION PLATE WITH INTRAMEDULLARY ANATOMICAL FIBULAR ALLOGRAFT FOR PROXIMAL HUMERUS FRACTURES IN OLDER PEOPLE AUTHORS: ZHU ZHENGGUO, QI HONGZHE, CHANG ZUHAO, CHEN HUA, TANG PEIFU CITATION: DOI: 10.3969/J.ISSN .2095-5227.2018.02.001 THE OBJECTIVE OF THIS STUDY IS TO COMPARE THE CLINICAL OUTCOMES AND COMPLICATIONS BETWEEN HEMIARTHROPLASTY (HA) AND LOCKING COMPRESSION PLATE (LCP) WITH FIBULAR ALLOGRAFT IN TREATMENT OF OLDER PATIENTS WITH COMMINUTED PROXIMAL HUMERUS FRACTURE (PHF). FROM JANUARY 2010 TO DECEMBER 2013, A TOTAL OF 49 OLDER PATIENTS WITH DISPLACED PHF WHO WERE TREATED BY HA (N = 20) OR LCP WITH FIBULAR ALLOGRAFT (N = 29) WERE INCLUDED IN THIS STUDY. FUNCTION WAS ASSESSED BY THE DISABILITY OF THE ARM, SHOULDER AND HAND (DASH) SCORE, CONSTANT-MURLEY SCORE (CMS), AND COMPLICATIONS WERE ALSO RECORDED IN EACH GROUP. ECHELON 5 WIRE(ETHICON) WAS THEN USED TO SUTURE THE SHOULDER SLEEVE WITH THE ANTEROSUPERIOR POSTERIOR ASPECT OF THE HUMERAL HEAD AND FIXED TO THE PLATE THROUGH THE PLATE HOLE. REPORTED COMPLICATIONS INCLUDED HUMERAL HEAD NECROSIS (N=1), INFECTION (N=1) IN CONCLUSION THE PRESENT RESULTS SHOW THAT PATIENTS TREATED BY LCP WITH FIBULAR ALLOGRAFT HAVE BETTER FUNCTIONAL OUTCOMES AND LOWER COMPLICATION RATES COMPARED TO PATIENTS TREATED BY HEMIARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207084 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention