BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE PRECISE

    MDR report key: 9209328 · Received October 18, 2019

    Report

    Report Number
    1717344-2019-01370
    Event Type
    Malfunction
    Date Received
    October 18, 2019
    Date of Event
    February 22, 2016
    Report Date
    October 18, 2019
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    UDI-DI
    10884524001463
    PMA / PMN Number
    K010010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: IS SUTURELESS THYROID SURGERY SAFE IN THE HANDS OF SURGICAL TRAINEES. A SINGLE CENTRE RETROSPECTIVE STUDY SOURCE: AMBE AND WASSENBERG BMC RES NOTES (2016) 9:118 DOI 10.1186/S13104-016-1940-7. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PLI 20: ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED FROM JANUARY 2011 UNTIL OCTOBER 2013, TWO HUNDRED AND EIGHT PATIENTS UNDERWENT THYROID SURGERY. SURGERY WAS PERFORMED IN 147 CASES (70.7 %) BY CONSULTANTS (CONSULTANT GROUP) AND IN 61 CASES (29.3 %) BY SURGICAL TRAINEES (TRAINEE GROUP). THE LIGASURE® PRECISE (COVIDIEN, BOULDER, CO, USA) WAS USED IN ALL CASES. POSTOPERATIVE HEMATOMA OCCURRED IN 7/208 PATIENTS OR 3.4%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001631 LIGASURE PRECISE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER LS1200 10884524001463

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other