BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER TURBOVAC 90 WITH INTEGRATED CABLE

    MDR report key: 1980247 · Received February 2, 2011

    Report

    Report Number
    2951580-2011-00017
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    January 1, 2004
    Report Date
    February 2, 2011
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K083306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AND A LOT NUMBER WAS NOT PROVIDED, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THE INSTRUCTIONS FOR USE FOR THE DEVICE HAS THE FOLLOWING WARNING: CAUTION: FAILURE TO ATTACH THE SUCTION ADAPTER MAY CAUSE THERMAL INJURY TO THE PHYSICIAN OR PT.

    Description of Event or Problem · 1

    PER JOURNAL ARTICLE RECEIVED ON 01/04/2011, THE PT SUSTAINED A SECOND-DEGREE DERMAL BURN OF THE SHOULDER REGION WHICH WAS NOTICED AFTER ARTHROSCOPIC ACROMIOPLASTY AND ROTATOR CUFF REPAIR. THE BURN COMPLICATION OCCURRED FROM SURGERY PERFORMED SOMETIME IN 2004 TO 2008. THE COMPLICATION WAS NOT RECOGNIZED AT THE TIME OF SURGERY, BUT RATHER, PRESENTED CLINICALLY 1 WEEK POSTOPERATIVELY AT THE TIME OF PORTAL SUTURE REMOVAL. THE BURN WAS DESCRIBED AS 0.5 INCH LINEAR STREAK ORIENTED ACCORDING TO GRAVITY IN THE LATERAL DECUBITUS POSITION. THE BURN WAS LOCATED ON THE PT'S ANTERIOR ASPECT OF THE SHOULDER. REPORTEDLY, THE ORIGIN OF THIS BURN APPEARED TO BE IN A LOCATION CORRESPONDING TO WHERE EFFLUENT COMING FROM THE END OF THE ABLATOR'S OUTFLOW TUBE WOULD LAND ON THE SKIN. THE PHYSICIAN REPORTED HE MOST COMMONLY PERFORMS SHOULDER ARTHROSCOPY WITH THE PT IN THE LATERAL DECUBITUS POSITION, AND THEREFORE, HE HAD NOT PREVIOUSLY FOUND A NEED TO ATTACH THE OUTFLOW TUBING (SUCTION LINE) OF THE SUPER TURBOVAC VENTED BIPOLAR RF DEVICE TO SUCTION (HOSPITAL VACUUM SOURCE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER TURBOVAC 90 WITH INTEGRATED CABLE ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other