BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROCARE

    MDR report key: 499397 · Received November 18, 2003

    Report

    Report Number
    MW1030304
    Event Type
    Malfunction
    Date Received
    November 18, 2003
    Date of Event
    September 30, 2003
    Report Date
    November 18, 2003
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING LEFT SHOULDER ARTHROSCOPY. DURING THE PROCEDURE, A SMALL CYLINDRICAL, TRANSPARENT, YELLOW OBJECT WAS VISUALIZED ON THE SCREEN. THE PHYSICIAN LOOKED FOR THE OBJECT BUT WAS UNABLE TO LOCATE IT. UNRELATED TO THIS EVENT, AN OPEN PROCEDURE NEEDED TO BE PERFORMED IN ORDER TO DO THE APPROPRIATE REPAIR. THE OBJECT COULD NOT BE LOCATED. AN ARTHROCARE TURBOVAC 90 WAND WAS UTILIZED DURING THE PROCEDURE. THE DEVICE WAS SENT FOR INVESTIGATION BASED ON INFORMATION FROM THE ARTHOCARE REPRESENTATIVE THAT THERE WAS A POTENTIAL THAT THE EPOXY RING COULD HAVE BEEN DISLODGED FROM THE PROBE. A LETTER DATED NOV 14, 2003 WAS RECEIVED FROM THE CO STATING THAT THE PRODUCT WAS EVALUATED AND FOUND TO HAVE A MISSING EPOXY RING. THE ARTHOCARE MEDICAL DIRECTOR WAS CONTACTED FOR ADVICE CONCERNING FURTHER USE. THESE DEVICES WITH THESE LOT NUMBERS HAVE BEEN REMOVED FROM STACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHROCARE TURBO VAC 90 WAND HRX ARTHROCARE CORP. TURBO VAC 90 WAND 3608431-2

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR