BEUDAMED
    FDA Adverse Event Other Summary report: N

    MULTIVAC TRISTAR 50 ARTHROWAND

    MDR report key: 1033542 · Received April 25, 2008

    Report

    Report Number
    2951580-2008-00030
    Event Type
    Other
    Date Received
    April 25, 2008
    Date of Event
    February 22, 2008
    Report Date
    April 21, 2008
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K072865
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. SINCE THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION AND THE LOT NUMBER WAS NOT KNOWN, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. IT WAS REPORTED THE DEVICE WAS NOT CONNECTED TO HOSP VACUUM EQUIPMENT AND SET TO 200 TO 400 MMHG VACUUM RANGE. INSTEAD, THE DEVICE WAS CONNECTED TO THE OUTFLOW TUBING OF AN FMS PUMP TO CONTROL SUCTION. THE ATTACHMENT OF THE DEVICE TO THE FMS IRRIGATION PUMP IS NOT PRESCRIBE IN THE ARTHROWAND INSTRUCTIONS FOR USE. IT IS UNK HOW THE DEVICE WILL OPERATE UNDER THESE CONDITIONS. THE INJURY TO THE PT MAY HAVE DUE TO INADEQUATE IRRIGATION, HOWEVER, NO CONCLUSION CAN BE MADE.

    Description of Event or Problem · 1

    ON MARCH 20, 2008, A CLINICAL INCIDENT INVOLVING A MULTIVAC TRISTAR 50 ARTHROWAND WAS REPORTED TO ARTHROCARE CORP. APPROX SIX WEEKS FOLLOWING THE INITIAL PROCEDURE PERFORMED ON TWO AND A HALF MONTHS EARLIER, A SECOND PROCEDURE WAS PERFORMED TO TREAT CARTILAGE DAMAGE TO THE INTERNAL FEMORAL ROLL WITH LOCAL BONE DEGENERATION AND A MARKED JOINT EFFUSION. IT WAS REPORTED THE PHYSICIAN SUSPECTED THE CARTILAGE DAMAGE WAS CAUSED BY THE EFFECT OF HEAT DURING THE RESECTION OF THE POSTERIOR HORN OF THE MEDIAL MENISCUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIVAC TRISTAR 50 ARTHROWAND ELECTROSURGICAL CUTTING & COAGULATION DEVICE GEI ARTHROCARE CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other