BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR RETURN ELECTRODE CABLE

    MDR report key: 2436080 · Received January 10, 2012

    Report

    Report Number
    1811755-2012-00076
    Event Type
    Malfunction
    Date Received
    January 10, 2012
    Date of Event
    December 12, 2011
    Report Date
    December 12, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    GXD
    PMA / PMN Number
    K032406
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RECEIVED AT THE MFR FOR TESTING. AN EVAL WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A F/U REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN RF ABLATION. THE STRYKER DEVICE INDICATED AN IMPEDANCE ERROR AFTER IT WAS CONNECTED TO THE PT. A BACK-UP DEVICE WAS USED THAT WAS FROM ANOTHER MFR (NAME UNK). THIS GENERATOR SHOCKED THE PT. THE CASE WAS COMPLETED AND DID NOT NEED TO BE RESCHEDULED. THERE WAS NO INJURY OR ADVERSE CONSEQUENCES WITH THE USE OF THE STRYKER PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR RETURN ELECTRODE CABLE GXD STRYKER INSTRUMENTS KALAMAZOO 08045

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK