BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON FLEX 60 POWERED PLUS ENDOPATH STAPLER ARTICULATING ENDOSCOPIC LINEAR CUT

    MDR report key: 21468141 · Received February 26, 2025

    Report

    Report Number
    3005075853-2025-01516
    Event Type
    Injury
    Date Received
    February 26, 2025
    Date of Event
    July 3, 2024
    Report Date
    February 26, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 2/26/2025. 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 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: DOES ANTRUM SIZE MATTER IN SLEEVE GASTRECTOMY? VOLUME II-A. RETROSPECTIVE MULTICENTRIC STUDY WITH LONG-TERM FOLLOW-UP AUTHORS: CLAUDIO GAMBARDELLA, SIMONA PARISI, SALVATORE TOLONE, FRANCESCO SAVERIO LUCIDO, GIANMATTIA DEL GENIO, LUIGI BRUSCIANO, ROSETTA ESPOSITO, DOMENICO DE VITO, LUDOVICO DOCIMO AND FRANCESCO PIZZA CITATION: JOURNAL OF CLINICAL MEDICINE, 2024, 13, 3912. HTTPS: / / DOI.ORG/ 10.3390 / JCM13133912. THIS RETROSPECTIVE MULTICENTRIC STUDY AIMS TO ELUCIDATE THE IMPACT OF VARYING RESECTION DISTANCES FROM THE PYLORUS ON WEIGHT VARIATION, BODY MASS INDEX (BMI), AND PERCENTAGE OF EXCESS WEIGHT LOSS (%EWL) AT A 5-YEAR FOLLOW-UP POST-LSG. THE STUDY COMPARED SUBJECTS UNDERGOING LSG WITH GASTRIC RESECTIONS STARTING 2 CM VS. 6 CM FROM THE PYLORUS (WIDE ANTRECTOMY VERSUS SMALL ANTRECTOMY) AND ALSO ASSESSES DIFFERENCES IN FOOD TOLERANCE, REFLUX SYMPTOMATOLOGY, GERD HEALTH-RELATED QUALITY-OF-LIFE (GERD-HRQL) SCORES, AND OBESITY-RELATED DISEASES BETWEEN THE TWO COHORTS. BETWEEN JANUARY 1, 2015, AND DECEMBER 31, 2019, A TOTAL OF 597 PATIENTS WERE INCLUDED IN THE FINAL ANALYSIS, WITH A MEAN AGE OF 37.3 ± 7.3 YEARS. THE MEAN WEIGHT OF PATIENTS WAS 134.7 ± 35.2 KG, AND THEIR MEAN BMI WAS 44.8 ± 5.2 KG/M². THE COHORT CONSISTED OF 315 FEMALES (52.7%) AND 282 MALES (47.3%). ALL PATIENTS UNDERWENT LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG) AS PART OF THEIR BARIATRIC TREATMENT. THE PROCEDURE WAS PERFORMED BY EXPERIENCED SURGEONS, AND PATIENTS WERE DIVIDED INTO TWO GROUPS BASED ON THE RESECTION DISTANCE FROM THE PYLORUS: GROUP A (WIDE ANTRECTOMY AT 2 CM) AND GROUP B (SMALL ANTRECTOMY AT 6 CM). TO PERFORM THE GASTRECTOMY, A 60 MM ECHELON FLEX® (ETHICON INC., RARITAN, FRANKLIN TOWNSHIP, NJ, USA) STAPLER WAS USED AND GOLD CARTRIDGES AT THE ANTRUM LEVEL AND FINISHED WITH A BLUE ONE. THE MEAN FOLLOW-UP DURATION WAS 69.4 ± 2.2 MONTHS, WITH THE FINAL FOLLOW-UP AT 60 MONTHS. REPORTED COMPLICATIONS INCLUDED: ECHELON FLEX 60 POWERED PLUS ENDOPATH STAPLER ARTICULATING ENDOSCOPIC LINEAR CUT (ETHICON) ECHELON FLEX® LINEAR STAPLERS (60-MM GOLD MAGAZINES; ETHICON) ECHELON FLEX® LINEAR STAPLERS (60-MM BLUE MAGAZINES; ETHICON) - BLEEDING (N=2) TREATMENT: UNDERWENT REOPERATION WITHIN 30 DAYS, MANAGED LAPAROSCOPICALLY. IN CONCLUSION, PERFORMING LSG WITH RADICAL ANTRECTOMY MAY ENHANCE AND EXPEDITE WEIGHT LOSS AT THE 12-MONTH FOLLOW-UP BUT COMPROMISE FOOD TOLERANCE COMPARED TO LSG WITH LIMITED ANTRUM RESECTION. HOWEVER, THESE DIFFERENCES APPEAR TO DIMINISH BY THE 24-MONTH FOLLOW-UP. ADDITIONALLY, A SMALLER ANTRUM MAY PREDISPOSE PATIENTS TO GERO AND DE NOVO ESOPHAGITIS. THEREFORE, METICULOUS PREOPERATIVE PATIENT SELECTION IS RECOMMENDED. LARGER PROSPECTIVE STUDIES ARE NEEDED TO ADDRESS THIS ISSUE AND TO HIGHLIGHT THE INCIDENCE OF EACH VARIABLE IN THE FUTURE WEIGHT LOSS OF BARIATRIC PATIENTS UNDERGOING LSG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595074 ECHELON FLEX 60 POWERED PLUS ENDOPATH STAPLER ARTICULATING ENDOSCOPIC LINEAR CUT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention