BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER TURBOVAC 90 WITH INTEGRATED CABLE

    MDR report key: 2101158 · Received May 18, 2011

    Report

    Report Number
    2951580-2011-00067
    Event Type
    Other
    Date Received
    May 18, 2011
    Date of Event
    April 14, 2011
    Report Date
    May 18, 2011
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K083306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR INVESTIGATION. SINCE THE DEVICE WAS NOT RETURNED FOR INVESTIGATION, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. A LOT HISTORY RECORD REVIEW WAS PERFORMED. NO ABNORMALITIES WERE FOUND IN THE LOT HISTORY RECORD REVIEW. THE LOT MET ALL DEVICE SPECIFICATIONS. NO CONCLUSION CAN BE MADE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO ARTHROCARE THAT A PT UNDERWENT A KNEE ARTHROSCOPY PROCEDURE WITH ACL RECONSTRUCTION, USING A SUPER TURBOVAC 90 WITH INTEGRATED CABLE ARTHROWAND. ALLEGEDLY THE SCREEN FROM THE DISTAL TIP OF THE WAND FELL OFF IN THE PT'S KNEE. THE SURGEON LOOKED FOR THE SCREEN WITH THE VIDEO MONITOR, BUT COULD NOT LOCATE IT. THE SURGEON DECIDED THAT A SECOND PROCEDURE IS NOT NECESSARY AT THIS TIME. THERE WAS NO REPORTED PT ADVERSE EFFECT OR PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER TURBOVAC 90 WITH INTEGRATED CABLE ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORP. EZ02410-B

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other