BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 12277917 · Received August 4, 2021

    Report

    Report Number
    3005075853-2021-04459
    Event Type
    Injury
    Date Received
    August 4, 2021
    Date of Event
    September 22, 2020
    Report Date
    July 9, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PUBLICATION YEAR OF 2020 EXACT EVENT DATE UNK. 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.

    Description of Event or Problem · 1

    TITLE: MECHANISMS OF ESOPHAGEAL AND GASTRIC TRANSIT FOLLOWING SLEEVE GASTRECTOMY AUTHORS: YAZMIN JOHARI, ANAGI WICKREMASINGHE, PRADIPTA KISWANDONO, HELEN YUE, GERALDINE OOI, CHERYL LAURIE, GEOFFREY HEBBARD, PAUL BEECH, KENNETH YAP, WENDY BROWN, PAUL BURTON CITATION: OBESITY SURGERY (2021); 31:725¿737. DOI: HTTPS://DOI.ORG/10.1007/S11695-020-04988-1 THE AIM OF THIS PROSPECTIVE STUDY WAS TO BETTER DEFINE THE KEY PHYSIOLOGICAL PROCESSES ASSOCIATED WITH THE GASTRIC SLEEVE RELATING TO THE MECHANISMS OF TRANSIT, INTRALUMINAL PRESSURIZATION, AND THE ROLE OF ESOPHAGEAL CONTRACTILE FUNCTION. A TOTAL OF 26 ASYMPTOMATIC PATIENTS (7 MALE AND 19 FEMALE; AGE 45.3 ± 15.0 YEARS; PREOPERATIVE BMI OF 47.5 ± 6.6) FOLOWING SLEEVE GASTRECTOMY (SG) UNDERWENT NUCLEAR SCINTIGRAPHY AND HIGH-RESOLUTION MANOMETRY. SLEEVE GASTRECTOMY WAS PERFORMED USING TRI-STAPLERS (ECHELON FLEX GST SYSTEM, ETHICON). REPORTED COMPLICATIONS INCLUDED POSTOPERATIVE MEDIAN REFLUX SCORE OF 12 (N=?), POSTOPERATIVE MEDIAN DYSPHAGIA SCORE OF 15 (N=?), TRIGGERED DEGLUTITIVE REFLUX (N=54.4%), MILDLY IMPAIRED ESOPHAGEAL PERISTALSIS (N=13), AND RAMPING EFFECT WITH SUBSEQUENT CONSECUTIVE LIQUID SWALLOWS DURING STATIONARY MANOMETRY (N=20). IN CONCLUSION, OUR STUDY HAD IDENTIFIED A NEW PHYSIOLOGICAL SCHEMA RELATING TO EMPTYING FOLLOWING GASTRIC SLEEVE AND DEFINED THE ROLE OF ESOPHAGEAL FUNCTION AND REFLUX EVENTS. IT IS HOPED THAT THIS WILL FORM A HIGHLY USEFUL BASIS FOR SURGEONS ADDRESSING KEY CHALLENGES ASSOCIATED WITH THE GASTRIC SLEEVE, LINK TO DEVELOPMENT OF IMPROVED DIAGNOSTIC ALGORITHMS, AND INFORM FURTHER INVESTIGATIONS OF THE MECHANISM OF WEIGHT LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170250 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1