BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBOVAC 90 3.5MM 90 DEG. SUCTION

    MDR report key: 1884035 · Received October 14, 2010

    Report

    Report Number
    2951580-2010-00094
    Event Type
    Injury
    Date Received
    October 14, 2010
    Date of Event
    August 5, 2010
    Report Date
    October 14, 2010
    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 WAS DISCARDED AND ISN'T AVAILABLE FOR INVESTIGATION. SINCE THE DEVICE WAS NOT RETURNED AND THE LOT WAS NOT PROVIDED, A COMPLETE INVESTIGATION CANNOT BE PERFORMED. IT WAS REPORTED THE PHYSICIAN DID NOT ATTACH THE SUCTION LINE TO A VACUUM SOURCE AS PRESCRIBED IN THE INSTRUCTIONS FOR USE. THE IFU PROVIDES THE FOLLOWING WARNING REGARDING INADEQUATE SUCTION: "FOR WANDS WITH SUCTION, FAILURE TO ATTACH THE SUCTION ADAPTER MAY CAUSE THERMAL INJURY TO THE PHYSICIAN OR PATIENT."

    Description of Event or Problem · 1

    DURING A SHOULDER ARTHROSCOPY PROCEDURE WITH A TURBOVAC 90 ARTHROWAND, THE PATIENT SUSTAINED BURNS OF THE UPPER ARM AND THE AXILLARY. THE BURNS REPORTEDLY CAME FROM THE FLUSHING LIQUID THAT RUNS OUT OF THE OPERATION FIELD. IT WAS REPORTED THAT THE SUCTION LINE WAS NOT ATTACHED TO THE HOSPITAL VACUUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURBOVAC 90 3.5MM 90 DEG. SUCTION ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORP. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other