BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTISYN Y-SHAPED MESH UNKNOWN PRODUCT

    MDR report key: 16620503 · Received March 27, 2023

    Report

    Report Number
    2210968-2023-02081
    Event Type
    Injury
    Date Received
    March 27, 2023
    Date of Event
    March 10, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K113205
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 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. 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. COMPONENT CODE: (B)(4) ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2023-02076, 2210968-2023-02077, 2210968-2023-02079, 2210968-2023-02080, 2210968-2023-02083, 2210968-2023-02084, 2210968-2023-02085, 2210968-2023-02086, 2210968-2023-02094. CITATION: HTTPS://DOI.ORG/10.1007/S00192-022-05134-4.

    Description of Event or Problem · 0

    TITLE: A ROBOTIC APPROACH TO MANAGEMENT OF FAILED SACROCOLPOPEXY AND SACROCOLPOPEXY COMPLICATIONS: A CASE SERIES THIS IS A RETROSPECTIVE CASE SERIES OF PATIENTS WHO UNDERWENT REVISION OF SCP BETWEEN JANUARY 2014 AND JANUARY 2021 AT A SINGLE INSTITUTION. NINETEEN PATIENTS WERE INITIALLY IDENTIFIED BY CPT CODES; TEN MET THE INCLUSION CRITERIA. Y MESH , 0 ETHIBOND SUTURE POLYPROPYLENE MESH WERE USED REPORTED COMPLICATIONS INCLUDED PATIENT 1- 61 YEARS OLD: MESH INTACT DETACHED FROM VAGINA, BOWEL ADHESIONS TO MESH PATIENT 3 - 55 YEARS OLD : MESH INTACT LOOSELY ATTACHED TO THE ANTERIOR LONGITUDINAL LIGAMENT. PATIENT 5 - 50 YEARS OLD : MESH INTACT DETACHED FROM VAGINA. PATIENT 6 - 70 YEARS OLD : MESH INTACT, DETACHED FROM CERVIX, MULTIPLE BOWEL ADHESIONS TO MESH AND VAGINA. PATIENT 8 - 53 YEARS OLD : SEROSANGUINOUS FLUID COLLECTION OVERLYING MESH ON ANTERIOR CERVIX WITH ETHIBOND SUTURES. PATIENT 9 - 77 YEARS OLD :SEROSANGUINOUS FLUID COLLECTION OVERLYING MESH, MESH EXPOSURE INTO THE VAGINA, BOWEL ADHESIONS TO THE VAGINAL APEX AND MESH, NEGATIVE SIGMOID BUBBLE TEST. IN CONCLUSION PROLAPSE RECURRENCE AND COMPLICATIONS AFTER SCP HAVE A SIGNIFICANT IMPACT ON PATIENT QUALITY OF LIFE. RECURRENT PROLAPSE AFTER SCP THEORETICALLY OCCURS BECAUSE OF MESH DETACHMENT FROM THE CERVIX/VAGINA, THE ANTERIOR LONGITUDINAL LIGAMENT, OR DISRUPTION/STRETCHING OF THE MESH. OUR CASE SERIES DEMONSTRATES THAT ABDOMINAL RE-EXPLORATION IS FEASIBLE AND VALUABLE IN THESE RARE CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739972 ARTISYN Y-SHAPED MESH UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTO ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Unknown Required Intervention