BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE

    MDR report key: 9170042 · Received October 8, 2019

    Report

    Report Number
    1717344-2019-01287
    Event Type
    Injury
    Date Received
    October 8, 2019
    Date of Event
    July 26, 2019
    Report Date
    October 8, 2019
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: (STREET1, MFR CITY, REGION, POSTAL CODE). 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.

    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. TITLE COMPARISON OF HYPOCALCEMIA RATES BETWEEN LIGASURE AND CLAMP-AND-TIE HEMOSTATIC TECHNIQUE IN TOTAL THYROIDECTOMIES SOURCE 2019 WILEY PERIODICALS, INC., VOLUME 41, 2019 (3677¿3683) DATE OF PUBLICATION: 11 JULY 2019. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    210 PATIENTS WHO HAD RECEIVED SUTURELESS THYROIDECTOMY WITH LIGASURE SMALL JAW (LSJ) (MEDTRONIC, (B)(4)) FROM (B)(6) 2016 TO (B)(6) 2018. PERMANENT RECURRENT LARYNGEAL NERVE PALSY OCCURRED IN 2 OF 3 THERMAL INJURIES IN THE LSJ GROUP DUE TO LATERAL THERMAL SPREAD IN THE LSJ GROUP. AND RECURRENT LARYNGEAL NERVE PALSY OCCURRED IN 11 NERVES IN THE LSJ GROUP (4 TRACTION INJURIES, 4 DISSECTION MECHANICAL INJURIES, AND 3 THERMAL INJURIES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961739 LIGASURE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER LF1212

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other