BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 13024979 · Received December 17, 2021

    Report

    Report Number
    1717344-2021-01663
    Event Type
    Malfunction
    Date Received
    December 17, 2021
    Date of Event
    October 20, 2021
    Report Date
    December 17, 2021
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: ALTERNATIVE SOURCES OF CAUTERY MAY IMPROVE POST-OPERATIVE HEMATOMA RATES BUT INCREASE OPERATIVE TIME IN THYROID SURGERY SOURCE: SCIENTIFIC REPORTS (2021) 11:22569. 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 COMPARED POSTOPERATIVE HEMATOMA RATES IN PATIENTS WHO UNDERWENT THYROID SURGERY BETWEEN 2016 AND 2018. PATIENTS WERE DIVIDED INTO TWO GROUPS: ONE GROUP USED CONVENTIONAL CAUTERY AND ONE GROUP USED ALTERNATIVE ENERGY DEVICES (LIGASURE OR A NON-MEDTRONIC DEVICE). THERE WERE 13,330 PATIENTS IN THE STUDY AND 8988 PATIENTS WERE IN THE ALTERNATIVE GROUP. COMPLICATIONS INCLUDED POST-OPERATIVE HEMATOMAS. INTERVENTIONS WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1931964 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown