BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE

    MDR report key: 11967959 · Received June 9, 2021

    Report

    Report Number
    3006451981-2021-00075
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    May 15, 2021
    Report Date
    June 9, 2021
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 A PROCEDURE, THE DEVICE DID NOT CUT AT ALL AND HAD PACKAGING ISSUE. THERE WAS ALSO A SEALING ISSUE WHERE NO REGRASP ALERT AND NO END TONE WAS HEARD. THE PATIENT HAD ONE DAY EXTENDED HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863840 LIGASURE ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MEDICAL PRODUCTS LF1212 S8AH717X

    Patients

    Seq Age Sex Outcome Treatment
    1