BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_ECHELON CIRCULAR POWERED STAPLER

    MDR report key: 14456761 · Received May 20, 2022

    Report

    Report Number
    3005075853-2022-03294
    Event Type
    Injury
    Date Received
    May 20, 2022
    Date of Event
    January 1, 2021
    Report Date
    May 19, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K163523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ONLY EVENT YEAR KNOWN: 2021. BATCH #: UNKNOWN. HEALTH EFFECT: CLINICAL CODE: GASTROINTESTINAL SYSTEM ((B)(4)). 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. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 FIELD AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: CLINICAL OUTCOMES WITH A POWERED CIRCULAR STAPLER FOR COLORECTAL ANASTOMOSES: AN INITIAL EXPERIENCE WITH 25 CONSECUTIVE CASES. AUTHORS: NAN ZUN TEO, MBBS, FRCS AND JAMES CHI-YONG NGU, MBBS, FRCS. CITATION CITE:MED DEVICES DIAGN ENG. 2017;2:94¿100. DOI: 10.1111/ANS.17034. THE ECHELON CIRCULAR POWERED STAPLER (CDHP, ETHICON) WAS RECENTLY INTRODUCED AND WAS TOUTED TO REDUCE ANASTOMOTIC LEAKS AND IMPROVE SURGEON ERGONOMICS. 1 AS ONE OF THE FIRST SOUTHEAST ASIAN CENTRES WHERE THE PRODUCT WAS LAUNCHED, WE PRESENT OUR EARLY CLINICAL OUTCOMES AND A TECHNICAL REVIEW OF THE CDHP BASED ON OUR INITIAL 25 CASES OF COLORECTAL ANASTOMOSES (CRA). A TOTAL OF 25 PATIENTS UNDERWENT COLORECTAL RESECTIONS AND CRA USING THE CDHP. REPORTED COMPLICATION INCLUDED THERE WERE TWO CASES OF IMMEDIATE STAPLE LINE BLEEDING. ONE STOPPED SPONTANEOUSLY AND THE OTHER REQUIRED SUTURE HAEMOSTASIS. ONE PATIENT HAD AN ANASTOMOTIC LEAK AND REQUIRED A TRANS-ANAL REPAIR OF THE ANASTOMOSIS WITH A DEFUNCTIONING STOMA. IN CONCLUSION THE CDHP HAS COMPARABLE CLINICAL OUTCOMES AND PROVIDES IMPROVED ERGONOMICS TO THE SURGEON. LARGER STUDIES ARE REQUIRED TO EVALUATE WHETHER REDUCED ANASTOMOTIC LEAK AND BLEEDING RATES IN BENCH TESTS WILL TRANSLATE TO CLINICAL SIGNIFICANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152352 UNK_ECHELON CIRCULAR POWERED STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention