BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE

    MDR report key: 9997862 · Received April 24, 2020

    Report

    Report Number
    1717344-2020-00472
    Event Type
    Malfunction
    Date Received
    April 24, 2020
    Date of Event
    February 11, 2020
    Report Date
    April 24, 2020
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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, AFTER A GOOD SEAL, THERE WAS LIGHT BLEEDING OF THE VESSEL WHICH WAS ABOUT 50 ML WITH THE UNIT AND WITH THE HANDPIECE. THE DOCTOR STATED THAT THE PATIENT WAS HEPARINIZED. SAME GENERATOR AND HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458253 LIGASURE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER LF1212

    Patients

    Seq Age Sex Outcome Treatment
    1