BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*ILS STRAIGHT STAPLER

    MDR report key: 17798256 · Received September 22, 2023

    Report

    Report Number
    3005075853-2023-06770
    Event Type
    Injury
    Date Received
    September 22, 2023
    Date of Event
    March 2, 2022
    Report Date
    November 13, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 11/13/2023. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN ANSWER : COULD NOT CONTACT WITH AUTHOR AND COULD NOT PROVIDE ANY RESPONSE.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 9/22/2023. D4 BATCH #: UNK. INVESTIGATION SUMMARY: 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 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

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: ADDITION OF JEJUNAI LATERAL ANASTOMOSIS IS NOT NECESSARY FOR GASTRIC-JEJUNUM POUCH ANASTOMOSIS FOLLOWING DISTAL GASTRECTOMY: A PROPENSITY-SCORE MATCHING ANALYSIS AUTHORS: GUANGYU CHEN, JUN WU, HENGDI ZHANG, YI WEN, GUODE LUO, ZHENYU CHEN, JUN ZHOU & YONGKUAN CAO. CITATION: JOURNAL OF INVESTIGATIVE SURGERY (2022);35(6):1263-1268, DOI: 10.1080/08941939.2022.2032489. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO MAKE A PROPENSITY-SCORE MATCHING ANALYSIS ON THE CLINICAL APPLICATION OF GASTRIC-JEJUNUM POUCH ANASTOMOSIS (GJPA) AND CONTINUOUS JEJUNAL POUCH AND RESIDUAL STOMACH ANASTOMOSIS COMBINED WITH JEJUNAL LATERAL ANASTOMOSIS (CONTIN-L). A TOTAL OF 287 PATIENTS WHO RECEIVED DISTAL GASTRECTOMY FROM JANUARY 2015 TO JANUARY 2019 WERE INCLUDED IN THE STUDY. THE ENROLLED PATIENTS WERE DIVIDED INTO THE GJPA GROUP (N=151; 89 MALE AND 62 FEMALE; MEAN AGE OF 53±8 YEARS) AND THE CONTIN-L GROUP (N=136; 72 MALE AND 64 FEMALE; MEAN AGE OF 57±10 YEARS) ACCORDING TO THE RECONSTRUCTION METHOD USED. GJPA WAS PERFORMED USING A 75-MM LINEAR CUTTING STAPLER (TLC75) AND A 29 MM TUBULAR STAPLER (SDH29), WHILE CONTIN-L PROCEDURE WAS PERFORMED USING A 75-MM LINEAR CUTTING STAPLER (TLC75), A 25 MM TUBULAR STAPLER (SDH25), AND A 29 MM TUBULAR STAPLER (SDH29). REPORTED COMPLICATIONS INCLUDE GASTROPLEGIA, ANASTOMOTIC LEAKAGE, ANASTOMOTIC BLEEDING, ABDOMINAL INFECTION, SERIOUS POST OPERATION COMPLICATIONS/MODIFIED CLAVIEN-DINDO CLASSIFICATION = 3, REFLUX GASTRITIS, AND ANASTOMOTIC ULCER. IN CONCLUSION, ADDITION OF JEJUNAL LATERAL ANASTOMOSIS IS NOT NECESSARY FOR GJPA FOLLOWING DISTAL GASTRECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104977 PROXIMATE*ILS STRAIGHT STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention