BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RF GEN OBSOLETE REPLACED BY 0406900000

    MDR report key: 2469720 · Received February 17, 2012

    Report

    Report Number
    1811755-2012-00585
    Event Type
    Malfunction
    Date Received
    February 17, 2012
    Date of Event
    December 20, 2011
    Report Date
    January 24, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    GXD
    PMA / PMN Number
    K063489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVAL WILL BE CONDUCTED, AND A F/U REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN A PT RETURNED FOR A F/U VISIT FOLLOWING A CERVICAL RADIOFREQUENCY ABLATION, THEY HAD A VISIBLE BURN ABOUT 2 1/2 BY 3 CM THAT WAS BLISTERED. THEY ALSO STATED THEY HAD NUMBNESS FOR A SHORT PERIOD OF TIME. THREE WEEKS FOLLOWING THE PROCEDURE, THE BLISTER HAD BROKEN, SHEDDING THE TOP LAYER OF SKIN. THE DOCTOR STATED A 100MM PROBE WITH A SINGLE LESION GENERATOR WAS USED WITH A THERMAL LESION AT 60 DEGREES FOR 80 SECONDS. ACCORDING TO THE SURGEON, THERE WAS NO INDICATION OF PROBLEMS WITH DEVICE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RF GEN OBSOLETE REPLACED BY 0406900000 GXD STRYKER INSTRUMENTS KALAMAZOO LES4387

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK