BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE

    MDR report key: 7436538 · Received April 17, 2018

    Report

    Report Number
    3006451981-2018-00280
    Event Type
    Malfunction
    Date Received
    April 17, 2018
    Date of Event
    March 20, 2018
    Report Date
    April 17, 2018
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS
    Product Code
    GEI
    PMA / PMN Number
    K102470
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH 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 USE, THE DEVICE DID NOT SEAL NOR CUT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278452 LIGASURE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MEDICAL PRODUCTS LF1212 S7KH704X

    Patients

    Seq Age Sex Outcome Treatment
    1