BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP

    MDR report key: 18332555 · Received December 14, 2023

    Report

    Report Number
    3005075853-2023-09446
    Event Type
    Injury
    Date Received
    December 14, 2023
    Date of Event
    July 25, 2022
    Report Date
    December 15, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036014584
    PMA / PMN Number
    K141952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4), DATE SENT: 12/14/2023. 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 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 FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 12/15/2023. DEVICE NOT RETURNED TO MANUFACTURER. H6.

    Description of Event or Problem · 0

    TITLE: LONG-TERM WEIGHT LOSS AFTER BARIATRIC PROCEDURES FOR MORBIDLY OBESE ADOLESCENTS AND YOUTH: A SINGLE-INSTITUTION ANALYSIS WITH UP TO 19-YEAR FOLLOW-UP AUTHORS: PAUL H. MCCLELLAND· KRYSTYNA KABATA· WOJCIECH GORECKI· ANTALYA JANO· MICHAEL E. ZENILMAN· PIOTR GORECKI CITATION: SURGICAL ENDOSCOPY (2023) 37:2224¿2238 HTTPS://DOI.ORG/10.1007/S00464-022-09434-0 THE OBJECTIVE OF THIS STUDY IS TO BETTER CHARACTERIZE THE LONG-TERM EFFECT OF THESE PROCEDURES IN YOUTH, WITH EMPHASIS ON OPTIMIZING SURGICAL SELECTION IN THIS AGE GROUP. BETWEEN NOVEMBER 2001 AND NOVEMBER 2019, A TOTAL OF 167 PATIENTS AGED 15¿24 YEARS WHO UNDERWENT ONE OF THREE LAPAROSCOPIC BARIATRIC PROCEDURES AND WERE PROSPECTIVELY MONITORED OVER 19 YEARS. LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS (LRYGB, N = 71), LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING (LAGB, N = 22), AND LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG, N = 74). PATIENTS UNDERGOING LRYGB HAD A LONGER MEDIAN HOSPITAL STAY LRYGB VS. 1.0 LAGB VS. 1.0 LSG, AND 6/71 REQUIRED POSTOPERATIVE ENDOSCOPIC DILATATION. LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING (LAGB) PROCEDURES WERE PERFORMED VIA A PARS FLACCIDA APPROACH INVOLVING TWO GASTROGASTRIC PLICATION SUTURES APPLIED ANTEROLATERALLY USING NONABSORBABLE 2¿0 ETHIBOND® POLYETHYLENE TEREPHTHALATE SUTURES (ETHICON ENDO-SURGERY, CINCINNATI, OHIO, USA); THESE PATIENTS WERE EITHER ADMITTED FOR OVERNIGHT OBSERVATION OR DISCHARGED ON THE DAY OF PROCEDURE. LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG) SURGERIES EMPLOYED AN ECHELON FLEX¿ 60 POWERED ENDOCUTTER (ETHICON ENDO-SURGERY, CINCINNATI, OHIO, USA) TO EXCISE THE GASTRIC FUNDUS AND BODY OVER A 34-FRENCH GASTRIC LAVAGE TUBE, STARTING 4 CM FROM THE PYLORUS AND ENDING 1 CM TO THE LEFT OF THE ANGLE OF HIS. REPORTED COMPLICATIONS INCLUDED ENDOSCOPIC DILATATION (N = 6), AND LYSIS OF ADHESIONS (N = 1). IN CONCLUSION, ALL PROCEDURES PROVIDED SIGNIFICANT AND DURABLE WEIGHT LOSS. LRYGB PATIENTS ACHIEVED THE BEST AND MOST SUSTAINED WEIGHT LOSS. LSG PATIENTS EXPERIENCED SECOND-BEST WEIGHT LOSS BETWEEN 1 AND 5 YEARS, WITH LOWEST CHANCE OF REOPERATION. LAGB PATIENTS HAD THE LEAST WEIGHT LOSS AND THE HIGHEST REOPERATION RATE. COMPARED TO OTHER FACTORS, TYPE OF BARIATRIC PROCEDURE WAS INDEPENDENTLY PREDICTIVE OF SUCCESSFUL WEIGHT LOSS OVER TIME. MORE STUDIES WITH LONG-TERM FOLLOW-UP ARE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114056 ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036014584

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention