BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON FLEX 60 POWERED PLUS ENDOPATH STAPLER ARTICULATING ENDOSCOPIC LINEAR CUT

    MDR report key: 14517562 · Received May 26, 2022

    Report

    Report Number
    3005075853-2022-03460
    Event Type
    Injury
    Date Received
    May 26, 2022
    Date of Event
    April 6, 2021
    Report Date
    June 1, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 6/1/2022. UPON REVIEW OF THE INFORMATION PROVIDED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT AND IS BEING CONSIDERED NOT REPORTABLE. ADDITIONAL INFORMATION REQUESTED AND RECEIVED: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. I HAPPILY WANT TO INFORM YOU THAT THERE WAS NO PRODUCT RELATED COMPLICATION FOUND IN STUDY PATIENTS, (B)(6), (AUTHOR) B1 B2 D4 H1 H6.

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH # UNK. 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 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. 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: FEASIBILITY OF SAME-DAY DISCHARGE AFTER LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS USING REMOTE MONITORING AUTHORS: LEONTIEN M.G. NIJLAND1,2 & STEVE M.M. DE CASTRO1 & MARLOU VOGEL3 & JAN-WILLEM F. COUMOU3 & PIM W.J. VAN RUTTE1 & RUBEN N. VAN VEEN1 CITATION: OBESITY SURGERY (2021); 31:2851¿2858. HTTPS://DOI.ORG/10.1007/S11695-021-05384-Z. THIS SINGLE-CENTER PROSPECTIVE FEASIBILITY STUDY AIMED TO EVALUATE THE FEASIBILITY OF SAME-DAY DISCHARGE AFTER LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS (RYGB) USING ADDITIONAL LIVE VIDEO CONSULTATION AND REMOTE MONITORING. A TOTAL OF 50 PATIENTS (47 WERE FEMALE; MEAN AGE OF 36 ± 10 (19¿55) YEARS; MEAN BMI OF 42 ± 4) UNDERGOING A PRIMARY RYGB WERE SELECTED AND POTENTIALLY TREATED FOLLOWING THE SAME-DAY DISCHARGE (SDD) PROTOCOL BETWEEN JUNE 2020 AND NOVEMBER 2020. SURGERY WAS PERFORMED USING A STAPLING DEVICE (ECHELON FLEX¿ 60-MM POWERED STAPLER) IN CREATING A STOMACH POUCH, STAPLED GASTROJEJUNOSTOMY, AND JEJUNO-JEJUNOSTOMY. THE MESENTERIC DEFECTS WERE CLOSED USING A COMPETITOR DEVICE. TROCAR SITES WERE CLOSED USING DISSOLVABLE SUTURES (MONOCRYL 3.0). REPORTED COMPLICATIONS INCLUDE POSTOPERATIVE FEVER (N=2); PERSISTENT POSTOPERATIVE NAUSEA AND VOMITING (N=1); ABDOMINAL PAIN (N=2) AND WERE DISCHARGED FROM THE ER AS THEY HAD MILD SYMPTOMS CONSISTING OF WITHOUT THE NEED OF AN INTERVENTION; NAUSEA AND VOMITING CAUSED BY A FISTULA BETWEEN POUCH AND BYPASSED STOMACH (N=1) REQUIRING READMISSION AND PATIENT WAS TREATED WITH A NASAL FEEDING TUBE FOR TEMPORARY ENTERAL FEEDING AND RECOVERED AFTER 6 WEEKS WITH DISAPPEARANCE OF THE FISTULA ON AN UPPER GASTROINTESTINAL SERIES AND WITHOUT THE NEED OF ANY OTHER INTERVENTIONS. IN CONCLUSION, THIS STUDY SUGGESTS THAT SDD IS FEASIBLE IN A SELECTED GROUP OF PATIENTS UNDERGOING RYGB SUPPORTED WITH ADDITIONAL REMOTE MONITORING. LARGER STUDIES SHOULD BE PERFORMED TO EVALUATE THE SAFETY, COSTS, GENERALIZABILITY OF SDD AFTER RYGB, AND THE VALUE OF ADDITIONAL REMOTE MONITORING FOR EARLY DETECTION OF POSTOPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2754191 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 Unknown Required Intervention| H