BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE V 5 MM SEALER DIVIDER

    MDR report key: 2212082 · Received July 8, 2011

    Report

    Report Number
    1717344-2011-00548
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 23, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL INSPECTION OF THE INCIDENT DEVICE REVEALED THAT THE DEVICE HAD BEEN USED. THE CERAMIC DOTS ON THE JAW INDICATED ENERGY TRANSFER AND THERE WAS BLOOD ON THE HINGE OF THE JAWS. THE INSULATING SLEEVE ON THE SHAFT OF THE DEVICE WAS SCRATCHED LATERALLY ABOUT TWO INCHES IN LENGTH EXPOSING BARE METAL IN TWO SMALL AREAS ALONG THIS SCRATCH. THE ELECTRODE FAILED HIPOT TESTING AT 3.0 KV. THE DEVICE WAS MOST LIKELY SCRATCHED DURING INSERTION INTO THE TROCAR. THE IFU FOR THIS DEVICE CAUTIONS THE CUSTOMER TO CAREFULLY INSERT AND WITHDRAW INSTRUMENTS FROM CANNULAS TO AVOID POSSIBLE DAMAGE TO THE DEVICES AND/OR INJURY TO THE PATIENT.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT DURING SURGERY PREP, IT WAS FOUND THAT THE BLACK SHAFT OF THE DEVICE WAS SCRATCHED. THE DEVICE WAS NOT USED FOR SURGERY. THE INCIDENT DEVICE WAS RETURNED AND A VISUAL INSPECTION CONFIRMED THE SCRATCHES ON THE SHAFT OF THE DEVICE. THE DEVICE FAILED HIPOT TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE V 5 MM SEALER DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK