BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RF GEN OBSOLETE REPLACED BY 0406900000

    MDR report key: 3192124 · Received June 27, 2013

    Report

    Report Number
    0001811755-2013-01467
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 31, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GXD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE. THE DEVICE HAS BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY THE MANUFACTURER AND THE COMPLAINT COULD NOT BE CONFIRMED. DUE TO THE FACT THAT NO FAILURES WERE CONFIRMED AND NO FURTHER INFORMATION COULD BE OBTAINED RELATED TO THE ALLEGED EVENT, NO FURTHER ROOT CAUSE DETERMINATION WAS POSSIBLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS HAVING DIFFICULTY WITH TEMPERATURE REGULATION. IN ADDITION THE POWER BUTTON WAS NOT FUNCTIONING PROPERLY. THE CUSTOMER REPORTED THAT THIS CAUSED A DELAY IN THE PROCEDURE BUT THE LENGTH OF THE DELAY IS UNKNOWN BY THE ACCOUNT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS HAVING HAVING DIFFICULTY WITH TEMPERATURE REGULATION. IN ADDITON THE POWER BUTTON WAS NOT FUNCTIONING PROPERLY. THE CUSTOMER REPORTED THAT THIS CAUSED A DELAY IN THE PROCEDURE BUT THE LENGTH OF THE DELAY IS UNKNOWN BY THE ACCOUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292781 RF GEN OBSOLETE REPLACED BY 0406900000 GENERATOR, LESION, RADIOFREQUENCY GXD STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1