BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 15659058 · Received October 24, 2022

    Report

    Report Number
    3005075853-2022-07158
    Event Type
    Injury
    Date Received
    October 24, 2022
    Date of Event
    January 4, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE OF EVENT: PUBLICATION DATE, EXACT EVENT DATE UNK. DATE SENT: 10/24/2022. BATCH #UNK. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS PROVIDED: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. NO FURTHER INFORMATION WILL BE PROVIDED BECAUSE WE CAN¿T GET ANY ADDITIONAL INFORMATION FROM THE AUTHOR. 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. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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: DIVISION OF THE PANCREAS AT THE NECK REDUCES POSTOPERATIVE PANCREATIC FISTULA IN LAPAROSCOPIC DISTAL PANCREATECTOMY: COMPARISON OF PANCREATIC DIVISION AT THE BODY AUTHORS: NAN ZHANG, KAI XU, XIANGQIAN SU SEIKO HIRONO, MANABU KAWAI, KEN-ICHI OKADA, MOTOKI MIYAZAWA, YUJI KITAHATA, RYOHEI KOBAYASHI, KEIJI HAYATA, SHINYA HAYAMI, MASAKI UENO, HIROKI YAMAUE. CITATION: PANCREATOLOGY 21 (2021), 480-486; HTTPS://DOI.ORG/10.1016/J.PAN.2020.12.021. THE PRESENT STUDY INVESTIGATES THE PERIOPERATIVE OUTCOMES AS WELL AS LONG-TERM OUTCOMES IN PATIENTS WITH LAPAROSCOPIC SURGERY, INCLUDING THE FREQUENCY OF DIABETES MELLITUS AND BODY WEIGHT CHANGE. WE EVALUATE WHICH SITE OF PANCREATIC DIVISION, NECK OR BODY, HAS BETTER OUTCOMES AFTER LAPAROSCOPIC DISTAL PANCREATECTOMY. BETWEEN DECEMBER 2009 AND MAY 2020, 88 PATIENTS WHO UNDERWENT LAPAROSCOPIC DISTAL PANCREATECTOMY WERE INCLUDED IN THE STUDY. THERE WERE 42 MALES AND 46 FEMALES WITH A MEDIAN AGE OF 70 YEARS (RANGE: 14-86 YEARS) AND A MEAN BMI OF 19 KG/M2. THE PANCREAS WAS DIVIDED AT THE NECK DURING LAPAROSCOPIC DISTAL PANCREATECTOMY IN 46 PATIENTS AND AT THE BODY IN 42 PATIENTS. BETWEEN DECEMBER 2009 AND JUNE 2014, 8 PATIENTS HAD PANCREATIC PARENCHYMA THAT WAS TRANSECTED WITH ENDOSCOPIC LINEAR STAPLER, USING ECHELON FLEX ECR (ETHICON ENDO-SURGERY). BETWEEN JULY 2014 AND MAY 2020, THE REST OF THE PATIENTS UNDERWENT THE PROCEDURE USING COMPETITORS¿ DEVICES. THE REPORTED COMPLICATIONS INCLUDED PANCREATIC FISTULA WITH BIOCHEMICAL LEAKS (N=?), PANCREATIC FISTULA GRADE B (N=?), HEMORRHAGE RELATED TO PANCREATIC FISTULA (N=?), SEVERE MORBIDITY (N=?). IN CONCLUSION, THIS STUDY SUGGESTS THAT THE PANCREATIC DIVISION AT NECK MIGHT REDUCE THE GRADE B/C POSTOPERATIVE PANCREATIC FISTULA INCIDENCE AFTER LDP, COMPARED TO DIVISION AT BODY. A POTENTIAL REASON IS THAT THE PANCREAS AT THE BODY IS THICKER THAN THAT AT NECK. HOWEVER, FURTHER LARGE-SCALE STUDIES ARE NECESSARY TO CONFIRM OUR RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2148668 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention