BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 21490938 · Received February 28, 2025

    Report

    Report Number
    1717344-2025-00294
    Event Type
    Injury
    Date Received
    February 28, 2025
    Date of Event
    January 4, 2025
    Report Date
    February 28, 2025
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EUROPEAN JOURNAL OF OBSTETRICS GYNECOLOGY AND REPRODUCTIVE BIOLOGY / ADEVIYE ATILGAN / EUROPEAN JOURNAL OF OBSTETRICS GYNECOLOGY AND REPRODUCTIVE BIOLOGY 306 (2025) 112¿116 / HTTPS://DOI.ORG/10.1016/J.EJOGRB.2025.01.005 / AVAILABLE ONLINE 13 JANUARY 2025 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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 INCLUDING 42 CASES OF VAGINAL HYSTERECTOMY (VH) WITH SUBSEQUENT TRANSVAGINAL NATURAL ORIFICE TRANSLUMINAL ENDOSCOPIC SURGERY USING ONLY EPIDURAL ANESTHESIA FOR APICAL PROLAPSE WAS COMPLETED BETWEEN MARCH 2019 AND JANUARY 2022. LIGASURE WAS USED DURING THE VH FOR MESOOVARIUM DISSECTION AND INFUNDIBULOPELVIC LIGAMENT COAGULATION AND LIGATION. ONE INTRAOPERATIVE COMPLICATION OF RIGHT URETER TRANSECTION OCCURRED DURING THE VH REQUIRING GENERAL ANESTHESIA AND CONVERSION TO CONVENTIONAL LAPAROSCOPY TO PERFORM URETERAL REANASTOMOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596460 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention