BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE

    MDR report key: 8067489 · Received November 13, 2018

    Report

    Report Number
    3006451981-2018-00630
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Date of Event
    April 23, 2018
    Report Date
    November 13, 2018
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    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 THYROIDECTOMY, THE DEVICE DID NOT SEAL WITH END TONE HEARD. BLEEDING WAS LESS THAN 250CC FROM TRANSECTING VESSELS. A DEVICE WAS USED TO CLOSE THE BLEEDING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904401 LIGASURE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MEDICAL PRODUCTS LF1212 S7LH719X

    Patients

    Seq Age Sex Outcome Treatment
    1