BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE

    MDR report key: 8519181 · Received April 16, 2019

    Report

    Report Number
    3006451981-2019-00062
    Event Type
    Malfunction
    Date Received
    April 16, 2019
    Date of Event
    March 15, 2019
    Report Date
    April 16, 2019
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING CORONARY BY PASS PROCEDURE, THE DEVICE GRASPED THE TISSUE BUT THE FUSION DID NOT WORK THAT RESULTED TO BLEEDING OF LESS THAN 250CC. AN END TONE WAS HEARD BUT NO REGRASP ALARM. A NEW DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311789 LIGASURE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MEDICAL PRODUCTS LF1212 S8JH738X

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR