BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE

    MDR report key: 8422165 · Received March 14, 2019

    Report

    Report Number
    1717344-2019-00337
    Event Type
    Malfunction
    Date Received
    March 14, 2019
    Date of Event
    February 18, 2019
    Report Date
    March 14, 2019
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 THE PROCEDURE, THE EXACT DEVICE WAS CONNECTED TO A GENERATOR AND USED, THE SEALING WAS WORSE THAN USING A SMALL JAWS DEVICE WITH A GENERATOR AND THERE WAS MORE BLEEDING THAN SMALL JAWS DEVICE. END TONE WAS HEARD. NO BLEEDING OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. SURGICAL TIME WAS NOT EXTENDED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214325 LIGASURE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER LF1212

    Patients

    Seq Age Sex Outcome Treatment
    1