BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATAFIX UNKNOWN

    MDR report key: 21511574 · Received March 3, 2025

    Report

    Report Number
    2210968-2025-02270
    Event Type
    Injury
    Date Received
    March 3, 2025
    Date of Event
    June 7, 2024
    Report Date
    March 3, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, 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. 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 SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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 NUMBER HAS NOT BEEN PROVIDED. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATIONS : OBESITY SURGERY (2024) 34:3553-3560. HTTPS://DOI.ORG/10.1007/S11695-024-07357-4.

    Description of Event or Problem · 0

    TITLE : PERIOPERATIVE OUTCOMES USING SINGLE-FIRE STAPLER. 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 (B)(6) 2022. DATA FROM THESE PATIENTS WAS COMPARED TO 3829 PATIENTS WHO UNDERWENT LSG USING A SEQUENTIAL STAPLE FIRING TECHNIQUE FROM (B)(6) 2016-(B)(6) 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. THE REPORTED COMPLICATION INCLUDED BLEED BY 72 H (N=13), LEAK BY 30 D (N=8), STRICTURE BY 30 D (N=4), ORGAN SPACE SSI (N=6), AND SUPERFICIAL INCISIONAL SSI (N=29). 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
    806292 STRATAFIX UNKNOWN SUTURE, SURGICAL, ABSORBABLE, (POLIGLECAPRONE 25) NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other