BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE

    MDR report key: 14626274 · Received June 7, 2022

    Report

    Report Number
    1717344-2022-00695
    Event Type
    Injury
    Date Received
    June 7, 2022
    Date of Event
    September 4, 2021
    Report Date
    June 20, 2022
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    UDI-DI
    10884521705913
    PMA / PMN Number
    K170869
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: LATERAL APPROACH USING GRASPING TECHNIC FOR UNIPORTAL MAJOR LUNG RESECTION SOURCE: GENERAL THORACIC AND CARDIOVASCULAR SURGERY (2022) 70:104¿106 / PUBLISHED ONLINE: 20 SEPTEMBER 2021. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, D1, D4, D8, G3, G4 (510K) NEW INFORMATION HAS BEEN RECEIVED, AND REASSESSMENT OF THE COMPLAINT FOUND THAT IT IS NO LONGER A REPORTABLE ISSUE. THE EVENT IS NO LONGER ASSOCIATED WITH A SERIOUS INJURY OR POTENTIAL FOR SERIOUS INJURY WITH REOCCURRENCE. 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 SOURCE OF STUDY PERFORMED BETWEEN OCTOBER 2015 AND APRIL 2021, A RETROSPECTIVE STUDY ANALYZED OUTCOMES OF PATIENTS WHO UNDERWENT PULMONARY LOBECTOMY AND LYMPH NODE DISSECTION WITH A UNIPORTAL LATERAL APPROACH FOR LUNG CANCER. LIGASURE MARYLAND WAS USED AS AN ENERGY DEVICE. THERE WERE 193 PATIENTS IN THE STUDY AND COMPLICATIONS INCLUDED CHYLOTHORAX, AND PULMONARY ARTERY INJURY IN ONE PATIENT THAT REQUIRED CONVERSION TO THORACOTOMY.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED BETWEEN (B)(6) 2015 AND (B)(6) 2021, A RETROSPECTIVE STUDY ANALYZED OUTCOMES OF PATIENTS WHO UNDERWENT PULMONARY LOBECTOMY AND LYMPH NODE DISSECTION WITH A UNIPORTAL LATERAL APPROACH FOR LUNG CANCER. LIGASURE MARYLAND WAS USED AS AN ENERGY DEVICE. THERE WERE (B)(4) PATIENTS IN THE STUDY AND COMPLICATIONS INCLUDED CHYLOTHORAX, AND PULMONARY ARTERY INJURY IN ONE PATIENT THAT REQUIRED CONVERSION TO THORACOTOMY. COMPLICATIONS WERE NOT RELATED TO THE DEVICE. THERE WAS NO PARTICULAR PROBLEM WITH EITHER THE LIGASURE OR THE COMBINED GENERATOR, AND THEY SAID THAT THERE WAS A POSSIBILITY OF ¿THERMAL DAMAGE¿ DUE TO THE PROCEDURE AND THE ENERGY DEVICE. LATERAL APPROACH USING GRASPING TECHNIC FOR UNIPORTAL MAJOR LUNG RESECTION. (B)(6) 2021. TAKASHI SUDA GENERAL THORACIC AND CARD IOVASCULAR SURGERY (2022)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578046 LIGASURE ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER LF1937 10884521705913

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention