BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT BIPOLAR RESECTION CORD STORZ

    MDR report key: 3823635 · Received February 28, 2014

    Report

    Report Number
    1717344-2014-00114
    Event Type
    Malfunction
    Date Received
    February 28, 2014
    Report Date
    January 30, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE ARCED DURING USE. THE CUSTOMER DID NOT KNOW OF ANY INJURY. INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE DEVICE FAILED HIPOT TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124027 FT BIPOLAR RESECTION CORD STORZ STORZ CORD GEI COVIDIEN LP Q619X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK