BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 13110992 · Received December 29, 2021

    Report

    Report Number
    1717344-2021-01698
    Event Type
    Injury
    Date Received
    December 29, 2021
    Date of Event
    November 22, 2020
    Report Date
    December 29, 2021
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: THE CIRCUMSTANCES IN WHICH RECURRENT LARYNGEAL NERVE PALSY OCCURS AFTER SURGERY FOR BENIGN THYROID DISEASE: A RETROSPECTIVE STUDY OF 1026 PATIENTS. SOURCE: J LARYNGOL OTOL 2021; 135: 640¿643 PUBLISHED ONLINE: 14 JUNE 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 OUTCOMES OF PATIENTS WHO UNDERWENT SURGERY FOR BENIGN THYROID DISEASE BETWEEN 2013 AND 2019. LIGASURE (SMALL JAW) OR SUTURE WAS USED TO COAGULATE OR LIGATE VESSELS. THERE WERE 1026 PATIENTS IN THE STUDY, 809 OF WHICH UNDERWENT TOTAL THYROIDECTOMY AND 217 UNDERWENT UNILATERAL LOBECTOMY WITH ISTHMUSECTOMY, AND POSTOPERATIVE COMPLICATIONS INCLUDED: RECURRENT LARYNGEAL NERVE PALSY DUE TO HEMATOMA IN TWO PATIENTS. DRAINAGE WAS REQUIRED. OTHER CAUSES OF RECURRENT LARYNGEAL NERVE PALSY WERE NOT RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2007672 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention