BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT BIPOLAR RESECTION CORD STORZ

    MDR report key: 3101787 · Received April 30, 2013

    Report

    Report Number
    1717344-2013-00264
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Report Date
    April 3, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE BLACK CONNECTOR SHOWED SIGNS OF ARCING. THE HIGH RESISTANCE CONNECTION PRESENT BETWEEN THE RESECTOSCOPE ELECTRODE AND CONNECTOR SOCKET LEAD TO SPARKING AND A HOLE IN INSTRUMENT CONNECTOR SIDE (BLACK CONNECTOR). THIS WOULD HAVE CONTRIBUTED TO THE CUSTOMERS REPORT OF THE CORD MELTED. THE CONNECTOR FAILED HI-POT TESTING. NEW DIMENSIONS HAVE BEEN INCORPORATED INTO A NEW REVISION FOR THE FT0021S PART DRAWING ON ENGINEERING CHANGE ORDER (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A GYNECOLOGY PROCEDURE THE PT 'JUMPED' SOME TIME DURING USE OF THE PRODUCT. THE CABLE WAS CHECKED AND THE OPERATING TEAM NOTICED IT HAD MELTED. INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE DEVICE FAILED HI-POT TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187778 FT BIPOLAR RESECTION CORD STORZ STORZ CORD GEI COVIDIEN LP 0D001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK