BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE

    MDR report key: 9293993 · Received November 7, 2019

    Report

    Report Number
    1717344-2019-01478
    Event Type
    Malfunction
    Date Received
    November 7, 2019
    Date of Event
    March 13, 2018
    Report Date
    November 7, 2019
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT SOLD IN US AND IS 510(K) EXEMPT. THIS REPORT IS ASSOCIATED TO A SIMILAR PRODUCT SOLD IN THE US WITH 510(K) NUMBER K102470. (B)(4). TITLE EFFICACY AND SAFETY OF LIGASURE¿ SMALL JAW INSTRUMENT IN THYROIDECTOMY: A 1-YEAR PROSPECTIVE OBSERVATIONAL STUDY SOURCE EUROPEAN ARCHIVES OF OTO-RHINO-LARYNGOLOGY, DATE OF PUBLICATION: 13 MARCH 2018. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCES, THE PURPOSE OF THIS SINGLE CENTER, PROSPECTIVE, OBSERVATIONAL STUDY IS TO COMPARE THE EFFICACY AND SAFETY PROFILES OF LIGASURE¿ SMALL JAW INSTRUMENT (LSJI; MEDTRONIC, BOULDER, CO, USA) VERSUS CONVENTIONAL TECHNIQUE IN PATIENTS UNDERGOING OPEN THYROIDECTOMY. PATIENTS WHO UNDERWENT THYROIDECTOMY BETWEEN SEPTEMBER 2013 AND SEPTEMBER 2014 WERE INCLUDED. A TOTAL OF 842 PATIENTS UNDERGOING THYROIDECTOMY EITHER WITH CONVENTIONAL METHOD (N = 440) OR WITH LSJI (N = 402) WERE ENROLLED. THERE WAS POST-OP BLEEDING IN 2 PATIENTS. THE BLEEDING WAS REPORTED TO BE LESS THAN 50 MILLILITERS. ARTICLE: KE-JING WANG, 2018, CROSSMARK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1086665 LIGASURE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER LF1212

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR