BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 20797793 · Received November 27, 2024

    Report

    Report Number
    1717344-2024-02142
    Event Type
    Injury
    Date Received
    November 27, 2024
    Date of Event
    September 30, 2024
    Report Date
    November 27, 2024
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    METTE VOLD HANSEN, RASMUS REINKE, STEFANO CHRISTIAN LONDERO, LARS ROLIGHED, CLINICAL EVALUATION OF COOLSEAL - A NEW, SAFE, AND FAST VESSEL SEALING DEVICE IN TOTAL THYROIDECTOMY, ENDOCRINE REGULATIONS, VOL. 58, NO. 3,181¿186, 2024. DOI:10.2478/ENR-2024-0021 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 COMPARED THE SAFETY OF LIGASURE AND A COMPETITOR DEVICE DURING TOTAL THYROIDECTOMY BETWEEN JANUARY 2021 AND JUNE 2023. OF THE 171 PATIENTS INCLUDED IN THE STUDY, HEMOSTASIS WAS ACHIEVED BY CONVENTIONAL LIGATION IN 117 PATIENTS, LIGASURE IN 34 PATIENTS AND A COMPETITOR DEVICE IN 20 PATIENTS. POSTOPERATIVE COMPLICATIONS IN THE LIGASURE GROUP INCLUDED HEMATOMA REQUIRING REOPERATION AND PERMANENT HYPOPARATHYROIDISM TRANSIENT AFFECTION OF CALCIUM AND PARATHYROID HORMONE (PTH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2452955 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Other| R