BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PWRD ECH FLEX 60MM EXACT CODE UNKNOWN

    MDR report key: 21608439 · Received March 14, 2025

    Report

    Report Number
    3005075853-2025-01986
    Event Type
    Injury
    Date Received
    March 14, 2025
    Date of Event
    June 7, 2024
    Report Date
    March 14, 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
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) DATE: 3/14/2204 D4: BATCH # UNK. 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 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.

    Description of Event or Problem · 0

    TITLE: PERIOPERATIVE OUTCOMES USING SINGLE-FIRE STAPLER AUTHORS: GREGORY D. FRITZ, ARYANA SHARRAK, JASON AUBREY, XHESIKA TOPALLI, ANTONIA VRANA, ANNE OPALIKIHN, GIUSEPPE M. ZAMBITO, THOMAS D. MARTIN, JAMES A. FOOTE, JOSHUA R. SMITH, JON L. SCHRAM. CITATIONS: OBESITY SURGERY (2024) 34:3553-3560 HTTPS:/ /DOI.ORG/ 10. 1007 / S 11695-024-07357-4. THE AIM OF THIS STUDY WAS TO STANDARDIZE THE SLEEVE GASTRECTOMY BY ELIMINATING INCONSISTENCIES AND SIMPLIFYING THE PROCEDURE. A TOTAL OF 807 LSG HAVE BEEN PERFORMED USING THE LATEST ITERATION OF THE TITAN STAPLER SINCE NOVEMBER 2022. DATA FROM THESE PATIENTS WAS COMPARED TO 3829 PATIENTS WHO UNDERWENT LSG USING A SEQUENTIAL STAPLE FIRING TECHNIQUE FROM SEPTEMBER 2016-SEPTEMBER 2021. ALL SEQUENTIAL FIRING LSGS WERE PERFORMED USING THE ECHELON 60-MM POWERED STAPLER (ETHICON¿ BIOSURGERY, INC., SOMERVILLE, NJ, USA) OVER A 38-40 FRENCH BOUGIE (VISIGI 3D¿, BOEHRINGER LABS, LLC, PHOENIXVILLE, PA, USA). IN ALL CASES, THE PROXIMAL 5-10 CM OF THE STAPLE LINE WAS OVERSEWN WITH 2-0 VICRYL (ETHICON¿ BIOSURGERY, INC., SOMERVILLE, NJ, USA) OR STRATAFIX (ETHICON¿ BIOSURGERY, INC., SOMERVILLE, NJ, USA) SECURING OMENTUM TO THE STAPLE LINE. TOPICAL HEMOSTATIC AGENTS WERE UTILIZED ON A CASE-BY CASE BASIS AT THE DISCRETION OF THE SURGEON. IN CONCLUSION, HERE WE REPORT OUR DATA ON PATIENTS UNDERGOING LSG USING THE LATEST TITAN STAPLER. WE SHOW THE DEVICE IS SAFE, EFFECTIVE, AND HAS RESULTED IN AN IMPROVEMENT IN LENGTH OF STAY, READMISSIONS, AND POST-OPERATIVE NAUSEA/VOMITING. WE ALSO NOTED REDUCED OPERATIVE TIME WITH THIS TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229196 PWRD ECH FLEX 60MM EXACT CODE UNKNOWN STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention