BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROCAPS ARTHROWAND

    MDR report key: 1061131 · Received June 18, 2008

    Report

    Report Number
    2951580-2008-00043
    Event Type
    Other
    Date Received
    June 18, 2008
    Date of Event
    April 15, 2008
    Report Date
    June 16, 2008
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K072865
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE WAS DISCARDED FOLLOWING PROCEDURE, A COMPLETE INVESTIGATION COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD WAS PERFORMED. THE LOT MET ALL DEVICE SPECIFICATIONS. THE PHYSICIAN REPORTED CONTINUOUS IRRIGATION WAS PROVIDED DURING THE PROCEDURE WITHOUT AN OUTFLOW CANNULA WHICH ALLOWS FOR THE REMOVAL OF THE IRRIGATION FLUID DURING THE PROCEDURE. THE PATIENT INJURY MAY HAVE BEEN DUE TO INADEQUATE CIRCULATION OF THE SALINE IRRIGATION FLUID WHICH MAY HAVE ALLOWED HEAT BUILD UP IN THE PATIENT'S JOINT. THE USE OF THE OUTFLOW CANNULA WOULD HAVE SERVED TO REMOVE IRRIGATION FLUID DURING THE PROCEDURE. THE INSTRUCTIONS FOR USE FOR THE DEVICE PROVIDES THE FOLLOWING CAUTION: "CAUTION: WHEN USING WANDS, ENSURE ADEQUATE FLOW AND CIRCULATION OF SALINE SOLUTION TO PREVENT UNNECESSARY HEATING OF THE SOLUTION THAT MAY RESULT IN TISSUE DAMAGE OR THERMAL INJURY. SINCE THE DEVICE WAS NOT RETURNED A COMPLETE INVESTIGATION COULD NOT BE PERFORMED, NO CONCLUSION CAN BE MADE.

    Description of Event or Problem · 1

    ON MAY 19, 2008, A CLINICAL INCIDENT INVOLVING A MICROCAPS ARTHROWAND WAS REPORTED TO ARTHROCARE CORPORATION. FOLLOWING A WRIST ARTHROSCOPY PROCEDURE OF THE RIGHT WRIST, THE PATIENT WAS REPORTED TO HAVE HAD A TENDON RUPTURE IN PATIENT'S HAND. IT WAS REPORTED THAT DURING THE ORIGINAL PROCEDURE THE MICROCAPS WAND BROKE AT THE DISTAL END AFTER A FEW MINUTES OF USE AND IT WAS OBSERVED THAT SHAFT APPEARED TO HAVE HEATED UP DURING USE. THE PROCEDURE WAS COMPLETED USING A MITEK VAPR DEVICE. THE PHYSICIAN HAD REPORTED THAT HE BELIEVES THE TENDON RUPTURE WAS DUE TO THE HEAT FROM THE MICROCAPS ARTHROWAND. IN 2008, A SECOND PROCEDURE WAS PERFORMED TO REPAIR THE RUPTURED TENDON. THE PATIENT IS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROCAPS ARTHROWAND ELECTROSURGICAL CUTTING & COAGULATION DEVICE GEI ARTHROCARE CORP. NA 9122170-A

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other