BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 17922079 · Received October 12, 2023

    Report

    Report Number
    1717344-2023-01259
    Event Type
    Injury
    Date Received
    October 12, 2023
    Date of Event
    May 30, 2023
    Report Date
    October 12, 2023
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: COMPARISON OF POSTOPERATIVE BLEEDING USING HARMONIC SCALPEL AND LIGASURE IN THYROID SURGERY: A 15-YEAR SINGLE-CENTRE RETROSPECTIVE STUDY SOURCE: ORIGINAL ARTICLE / MED GLAS (ZENICA) 2023; 20(2):229-234 / ACCEPTED: 30 MAY 2023 / DOI: 10.17392/1629-23. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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 THE USE OF LIGASURE AND ANOTHER DEVICE IN REGARDS TO POSTOPERATIVE BLEEDING IN PATIENTS WHO UNDERWENT THYROIDECTOMIES BETWEEN 2008 AND 2023. THERE WERE 718 PATIENTS IN THE LIGASURE GROUP AND 935 PATIENTS IN THE OTHER GROUP. 14 POSTOPERATIVE BLEEDINGS THAT OCCURRED TO PATIENTS OF GROUP A, 10 CASES INVOLVED MINOR HEMORRHAGES WHEREIN 4 PATIENTS REQUIRED REOPERATION. FROM THE TOTAL OF 6 POST OPERATIVE BLEEDING CASES THERE WHERE ALSO 4 CASES THAT NEEDED REOPERATION BUT ONLY 2 MINOR HEMORRHAGES FROM GROUP B. IN OUR STUDY, 12 CASES OF POST-OPERATIVE HEMATOMA WERE OBSERVED OUT OF THE TOTAL OF 718 THYROIDECTOMIES, WITH THE PATIENT UNDERGOING OPERATIVE EXPLORATION OF THE SURGICAL SITE IN CASES DUE TO PERSISTENT HEMORRHAGE AND AIRWAY OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1505584 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