BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 17959674 · Received October 18, 2023

    Report

    Report Number
    3005075853-2023-07596
    Event Type
    Injury
    Date Received
    October 18, 2023
    Date of Event
    July 18, 2023
    Report Date
    October 18, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    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: 10/18/2023. B3: PUBLICATION YEAR OF 2023. D4: BATCH # UNK. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING 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 DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. 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: IMPACT OF A CIRCULAR POWERED STAPLER ON PREVENTING ANASTOMOTIC LEAKAGE IN PATIENTS WITH LEFT-SIDED COLORECTAL CANCER: A RETROSPECTIVE STUDY AUTHOR(S): MASATSUNE SHIBUTANI, TATSUNARI FUKUOKA, YASUHITO LSEKI, HIROAKI KASASHIMA, KISHU KITAYAMA, AND KIYOSHI MAEDA. CITATION: SHIBUTANI ET AL. BMC SURGERY (2023) 23:205; HTTPS://DOI.ORG/10.1186/S 12893-023-021 04-5 . THE AIM OF THIS STUDY WAS TO COMPARE THE INCIDENCE OF ANASTOMOTIC LEAKAGE BETWEEN A CONVENTIONAL MANUAL CIRCULAR STAPLER AND THE ECHELON CIRCULAR¿ POWERED STAPLER (ECPS) IN PATIENTS WITH LEFT-SIDED COLORECTAL CANCER WHO UNDERWENT ANASTOMOSIS WITH THE DOUBLE STAPLING TECHNIQUE. BETWEEN JANUARY 2016 AND JULY 2022, 187 PATIENTS WITH LEFT-SIDED COLORECTAL CANCER WHO UNDERWENT ANASTOMOSIS WITH THE DOUBLE STAPLING TECHNIQUE WITH A CONVENTIONAL MANUAL CIRCULAR STAPLER (MANUFACTURER: UNKNOWN) OR THE ENDOPATH ENDOSCOPIC INTRALUMINAL STAPLER (ETHICON ENDO-SURGERY) (ECPS) DURING SURGERY WERE INCLUDED IN THE STUDY. THE MANUAL CIRCULAR STAPLER WAS USED IN 119 CASES WHICH INCLUDED 48 MALES AND 71 FEMALES WITH A MEDIAN AGE OF 68 YEARS (RANGE, 41- 87) AND A MEDIAN BMI OF 22.77 KG/M2 (RANGE, 15.26-32.19). THE ECPS WAS USED IN 68 CASES WHICH INCLUDED 32 MALES AND 36 FEMALES WITH A MEDIAN AGE OF 69 YEARS (RANGE, 42-91) AND A MEDIAN BMI OF 21.24 KG/M2 (RANGE, 14.84- 40.88). HIGH LIGATION OF THE INFERIOR MESENTERIC ARTERY WAS PERFORMED IN ALL CASES. INDOCYANINE GREEN FLUORESCENCE IMAGING WAS PERFORMED TO EVALUATE BLOOD PERFUSION IN PATIENTS WHO UNDERWENT SURGERY AFTER JUNE 2017. REPORTED COMPLICATIONS INCLUDED ANASTOMOTIC LEAKAGE (N=3) AND REOPERATION DUE TO ANASTOMOTIC (N=1). IN CONCLUSION, THE ECHELON CIRCULAR¿ POWERED STAPLER HAS THE POTENTIAL TO HELP REDUCE THE RATE OF ANASTOMOTIC LEAKAGE IN LEFT-SIDED COLORECTAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641432 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention