BEUDAMED
    FDA Adverse Event Other Summary report: N

    TOPAZ MICRODEBRIDER WITH INTEGRATED CABLE

    MDR report key: 2163686 · Received June 16, 2011

    Report

    Report Number
    2951580-2011-00080
    Event Type
    Other
    Date Received
    June 16, 2011
    Date of Event
    January 1, 2006
    Report Date
    June 16, 2011
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K080282
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF EVENT WAS REPORTED AS BETWEEN (B)(6) 2006 AND (B)(6) 2008. SINCE THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AND THE LOT NUMBER WAS NOT PROVIDED, A COMPLETE INVESTIGATION CANNOT BE PERFORMED. NO CONCLUSION CAN BE MADE.

    Description of Event or Problem · 1

    PER JOURNAL ARTICLE (PERCUTANEOUS BIPOLAR RADIOFREQUENCY MICRODEBRIDEMENT FOR RECALCITRANT PROXIMAL PLANTAR FASCIOSIS, THE JOURNAL OF FOOT & ANKLE SURGERY, SORENSON M. D. ET AL, 2011), IT WAS REPORTED THAT A PATIENT HAD UNDERGONE PERCUTANEOUS BIPOLAR RADIOFREQUENCY MICROFASCIOTOMY FOR THE TREATMENT OF RECALCITRANT PROXIMAL PLANTAR FASCIOSIS AND DEVELOPED FHL TENDONITIS. THE PRECISE CAUSE OF THIS COMPLICATION WAS NOT CLEARLY KNOWN ACCORDING TO THE PUBLICATION. IT WAS REPORTED IN THE ARTICLE THAT IT'S POSSIBLE THAT THE TOPAZ MICRODEBRIDER WAND MAY HAVE BEEN PASSED TO AN EXCESSIVE DEPTH, PLACING IT INTO, OR CLOSE TO, THE FHL TENDON OR ITS SHEATH. THE PATIENT IN QUESTION WAS ALSO DISSATISFIED WITH THE PROCEDURE, BASED ON THE FHL TENDINITIS THAT PERSISTED THROUGHOUT THE OBSERVATION PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOPAZ MICRODEBRIDER WITH INTEGRATED CABLE ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other