BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER TURBOVAC 90 WITH INTEGRATED CABLE

    MDR report key: 2181132 · Received July 22, 2011

    Report

    Report Number
    2951580-2011-00094
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 22, 2011
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K033584
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DEVICE WILL BE RETURNED FOR INVESTIGATION. TO DATE, THE DEVICE HAS NOT BEEN REC'D. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A SUBACROMIAL DECOMPRESSION PROCEDURE USING A SUPER TURBOVAC 90 WAND. THE PT REPORTEDLY SUSTAINED A SECOND DEGREE BURN ON THE RIGHT BREAST (THE INCISION AREA WAS NOT BURNED). THE PHYSICIAN STATED THAT THE BURN WAS TREATED AND HEALING W/O COMPLICATIONS, AND NO ADD'L PROCEDURES FOR THE BURN ARE RECOMMENDED. NO OTHER INFO WAS PROVIDED FOR THIS REPORT.

    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 EZ08010-A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other