BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 13661923 · Received March 3, 2022

    Report

    Report Number
    1717344-2022-00255
    Event Type
    Injury
    Date Received
    March 3, 2022
    Date of Event
    December 6, 2021
    Report Date
    March 3, 2022
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: VAGINAL APPROACH VERSUS LAPAROSCOPY FOR HYSTERECTOMY IN TRANSGENDER MEN SOURCE: JOURNAL OF GYNECOLOGY OBSTETRICS AND HUMAN REPRODUCTION 51 (2022) 102286 ACCEPTED 6 DECEMBER 2021. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY ANALYZED THE OUTCOMES OF THE VAGINAL APPROACH AND LAPAROSCOPY IN TRANSGENDER MEN UNDERGOING HYSTERECTOMY BETWEEN MAY 2017 AND JUNE 2020. IN THE VAGINAL APPROACH, LIGASURE WAS USED TO PERFORM BILATERAL SALPINGO-OOPHERECTOMY. LIGASURE WAS USED IN THE LAPAROSCOPY GROUP BUT IT IS NOT SPECIFIED HOW THE DEVICE WAS USED. THERE WERE 45 PATIENTS IN EACH GROUP AND THERE WAS ONE COMPLICATION IN EACH GROUP: BLADDER INJURY (VAGINAL GROUP) AND POSTOPERATIVE BLEEDING (LAPAROSCOPY GROUP). THE PATIENT WITH BLADDER INJURY REQUIRED CONVERSION TO OPEN PROCEDURE TO RESOLVE THE ISSUE. THE PATIENT WITH POSTOPERATIVE BLEEDING REQUIRED REOPERATION ON POST-OP DAY 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1654937 UNKNOWN LIGASURE INSTRUMENT GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male Required Intervention