BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TICRON

    MDR report key: 20560088 · Received October 29, 2024

    Report

    Report Number
    9612501-2024-02735
    Event Type
    Injury
    Date Received
    October 29, 2024
    Date of Event
    January 8, 2024
    Report Date
    October 29, 2024
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GAT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE: GÜLSEN DOGAN DURDAG, SONGÜL ALEMDAROGLU, SIRIN AYDIN, SEDA YÜKSEL SIMSEK, ERHAN SIMSEK, HÜSNÜ ÇELIK, 2024, SINGLE-CENTER EXPERIENCE OF LAPAROSCOPIC HYSTERECTOMY: ANALYSIS OF ONE THOUSAND FIVE HUNDRED AND FIFTEEN PATIENTS, JOURNAL OF THE TURKISH-GERMAN GYNECOLOGICAL ASSOCIATION 2024; 25: 144-51. DOI: 10.4274/JTGGA.GALENOS.2024.2023-9-12. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY AIMED TO EVALUATE THE CLINICAL FEATURES AND PERIOPERATIVE OUTCOMES OF PATIENTS WHO UNDERWENT LAPAROSCOPIC HYSTERECTOMY FOR BENIGN OR MALIGNANT INDICATIONS BETWEEN 2012 AND 2020. THE SURGICAL PROCEDURES PERFORMED WERE LAPAROSCOPIC HYSTERECTOMY WITH SALPINGECTOMY OR SALPINGO-OOPHORECTOMY, AND SACROCOLPOPEXY OR LYMPH NODE DISSECTION AND OMENTECTOMY. IN 152 PATIENTS SACROCOLPOPEXY WAS PERFORMED WITH MESH FIXATED TO THE VAGINAL CUFF AND PROMONTORY WITH NON-ABSORBABLE BRAIDED SUTURES. POSTOPERATIVE COMPLICATIONS RELATED TO MESH FIXATION INCLUDED: VAGINAL CUFF HEMATOMA IN 12 PERCENT AND DISCITIS ON ONE PATIENT. VAGINAL RE-SUTURING OR REOPERATION WERE REQUIRED TO TREAT VAGINAL CUFF HEMATOMA. ONE PATIENT REQUIRED REOPERATION TO REMOVE THE MESH DUE TO DISCITIS AFTER SACROCOLPOPEXY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915580 UNKNOWN TICRON SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT DAVIS & GECK CARIBE LTD UNKNOWN TICRON

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention