BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTISYN Y-SHAPED MESH UNKNOWN PRODUCT

    MDR report key: 20334851 · Received September 30, 2024

    Report

    Report Number
    2210968-2024-10397
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    March 2, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K113205
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. AN ATTEMPT HAS BEEN 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. CITATION: BMC SURGERY.VOL. 22:82.PAGES : 1-8. HTTPS://DOI.ORG/10.1186/S12893-022-01535.

    Description of Event or Problem · 0

    TITLE : TRANSVAGINAL SINGLE-PORT VERSUS MULTI-PORT LAPAROSCOPIC SACROCOLPOPEXY: A RETROSPECTIVE COHORT STUDY. THE AIM OF THIS STUDY IS TO COMPARE THE MIDDLE TERM CLINICAL OUTCOMES OF TRANSVAGINAL SINGLE-PORT LAPAROSCOPIC SACROCOLPOPEXY WITH MULTI-PORT LAPAROSCOPIC SACROCOLPOPEXY (LSC) FOR APICAL PROLAPSE. PATIENTS (N=89) WITH ADVANCED APICAL PROLAPSE WHO UNDERWENT EITHER TS-LSC OR LSC BETWEEN (B)(6) 2019 WERE ENROLLED. THERE WERE 46 SUBJECTS IN TS-LSC GROUP (92.0%) AND 43 SUBJECTS IN LSC GROUP (89.6%) IN THE ANALYSIS. AFTER THE HYSTERECTOMY WAS DONE, THE SINGLE-PORT DEVICE WAS ESTABLISHED. THE RIGHT SIDE OF THE PELVIC PERITONEUM WAS OPENED, FROM SACRAL PROMONTORY TO THE VAGINAL CUFF. THEN THE Y-SHAPED MESH WAS CLIPPED ACCORDING TO THE LENGTH OF VAGINAL WALL. THE LONG ARM OF MESH WAS ANCHORED TO THE LONGITUDINAL LIGAMENT LYING ON S1 VERTEBRAE WITH TENSION-FREE, USING ETHIBOND, NON-ABSORBABLE, SYNTHETIC AND MULTIFILAMENT SUTURES FROM ETHICON (SEEING IN FIG. 1A). THE REPORTED COMPLICATIONS INCLUDED MESH EXPOSURE ( N=6),DE NOVO SUI (N=1), CONSTIPATION (N=5), URINARY TRACT INFECTION (N=2), DYSPAREUNIA (N=3) AND RECURRENCE (N=4). IN CONCLUSION, TS-LSC WAS NOT INFERIOR TO LSC AT 2 YEARS. PATIENTS MAY BENEFIT FROM ITS MILD PAIN, BETTER COSMETIC EFFECT AND BETTER APICAL SUPPORT AS WELL AS GOOD SAFETY AND EFFICACY. TS-LSC IS A PROMISING CONSIDERABLE CHOICE FOR ADVANCED VAGINAL APICAL PROLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053205 ARTISYN Y-SHAPED MESH UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTO ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention