BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT BIPOLAR RESECTION CORD STORZ

    MDR report key: 3823688 · Received May 1, 2014

    Report

    Report Number
    1717344-2014-00359
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    March 3, 2014
    Report Date
    April 25, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND THE INVESTIGATION FOUND THE COMPLAINT MODE OF A MELTED/BURNED CORD WAS CONFIRMED. THE ARCING/SPARKING FAILURES OBSERVED ON THIS PRODUCT WERE PROBABLY DUE TO POOR CONTACT-TO-CONTACT IMPEDANCE. THE ROOT CAUSE FOR THE FAILURE CANNOT BE DETERMINED. THERE WERE NO INDICATIONS THE FAILURE WAS DUE TO A MANUFACTURING OR MATERIALS DEFECT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER JUST 7-9 PROCEDURES THE CABLE BURNS AND GENERATES SMOKE OR SPARKS. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261662 FT BIPOLAR RESECTION CORD STORZ STORZ CORD GEI COVIDIEN LP Q797X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK FORCETRIAD ENERGY PLATFORM, SERIAL#: (B)(4)