BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE

    MDR report key: 9744565 · Received February 24, 2020

    Report

    Report Number
    3006451981-2020-00027
    Event Type
    Injury
    Date Received
    February 24, 2020
    Date of Event
    February 7, 2020
    Report Date
    April 22, 2020
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D10, G4, H3, H6 H3 EVALUATION SUMMARY: ONE DEVICE WAS RECEIVED FOR EVALUATION. THE RETURNED PRODUCT MET SPECIFICATION AS RECEIVED. VISUAL INSPECTION FOUND NO DEFECTS. THE INVESTIGATION FOUND THAT THE TAGSCAN STUDY SHOWED THAT THERE WERE MULTIPLE (TWO) USERS. DEVICE IS A SINGLE-USE DEVICE. IT IS INTENDED NOT TO BE USED BY MULTIPLE USERS. FUNCTIONAL TESTING WAS PERFORMED WITH THE RETURNED DEVICES ON PORCINE KIDNEY TISSUE. MULTIPLE SEALS ON VARIOUS SIZE VESSELS WERE MADE WITH VISUALLY ACCEPTABLE RESULTS. ALL SEAL CYCLES WERE COMPLETED SATISFACTORY AND END TONES WERE HEARD INDICATING COMPLETED ACTIVATION CYCLES. THE INVESTIGATION FOUND THE DEVICE TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS. REFER TO THE PRODUCT INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON TISSUE SEALING. THE INSTRUCTIONS FOR USE (IFU) STATES, KEEP THE INSTRUMENT JAWS CLEAN. BUILD-UP OF ESCHAR MAY REDUCE THE SEAL AND / OR CUTTING EFFECTIVENESS. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, POST OPERATIVELY, THE DEVICE HAD AN INADEQUATE SEAL AND BLEEDING OCCURRED AFTER PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210941 LIGASURE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MEDICAL PRODUCTS LF1212 S8AH702X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other