BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBOVAC 90 ARTHROWAND

    MDR report key: 1517158 · Received October 28, 2009

    Report

    Report Number
    2951580-2009-00110
    Event Type
    Injury
    Date Received
    October 28, 2009
    Date of Event
    September 23, 2009
    Report Date
    October 23, 2009
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K083306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS REPORTED AS RETURNING FOR INVESTIGATION. A FOLLOW UP REPORT WILL BE COMPLETED AFTER THE RETURN OF THE DEVICE AND COMPLETION OF THE INVESTIGATION. THREE TURBOVAC 90 ARTHROWANDS WERE USED IN THE SAME PROCEDURE. TWO ADDITIONAL MEDWATCH REPORTS WILL BE FILED UNDER MEDWATCH NUMBERS 2951580-2009-00109 AND 2951580-2009-00111 FOR ADDITIONAL DEVICES.

    Description of Event or Problem · 1

    A CLINICAL INCIDENT INVOLVING THREE TURBOVAC 90 WANDS WAS REPORTED TO ARTHROCARE CORP. DURING A HIP ARTHROSCOPY PROCEDURE, THE PT SUSTAINED THIRD DEGREE BURN ON LEFT SIDE OF THE HIP, AND BURN OCCURRED DURING USE OF THE THIRD WAND. THE BURN WAS TREATED WITH A BANDAGE. THE PT WAS ADMINISTERED ANTIBIOTICS. IT WAS NOT KNOWN IF THE WAND WAS ATTACHED TO HOSP VACUUM AT 200 TO 400 MM HG ACCORDING TO THE INSTRUCTIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURBOVAC 90 ARTHROWAND ELECTROSURGICAL CUTTING & COAGULATION DEVICE GEI ARTHROCARE CORP. NA FJ162590-A

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other