BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE HS XTD DISP ELEC/CORD

    MDR report key: 2913846 · Received December 5, 2012

    Report

    Report Number
    1717344-2012-01213
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    October 24, 2012
    Report Date
    November 8, 2012
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE WAS RETURNED, EVALUATED AND FOUND TO FUNCTION WITHIN SPECIFICATION. THE DEVICE WAS TESTED FOR ACTIVATION AND SEALING FUNCTION ON SIMULATED TISSUE WITH ACCEPTABLE RESULTS. ADDITIONAL TESTING WAS DONE BY PERFORMING MULTIPLE SEALS OF VARIOUS SIZES ON PORCINE TISSUE AND ALL SEAL CYCLES WERE COMPLETED SATISFACTORILY. WE WERE UNABLE TO CONFIRM THE CUSTOMER¿S REPORT.

    Description of Event or Problem · 1

    THE CUSOMTER REPORTED THAT THE DEVICE DID NOT COAGULATE PROPERLY. NO ILL EFFECT TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE HS XTD DISP ELEC/CORD LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 236747X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK