BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI VUECATH SPINAL ENDOSCOPIC SYSTEM

    MDR report key: 1092163 · Received August 5, 2008

    Report

    Report Number
    2242816-2008-00117
    Event Type
    Malfunction
    Date Received
    August 5, 2008
    Date of Event
    June 25, 2008
    Report Date
    July 17, 2008
    Manufacturer
    EBI, L.P.
    Product Code
    HRX
    PMA / PMN Number
    K010179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED DEVICE OBSERVED THAT THE BODY OF THE CATHETER WAS SLIGHTLY SPLIT APART AND THAT A GUIDE WIRE WAS PARTIALLY INSERTED. INVESTIGATION CONFIRMED THAT THE GUIDE WIRE WOULD NOT ADVANCE THROUGH TO THE CATHETER. INVESTIGATION DETERMINED THAT THE GUIDE WIRE TUBE HAD BECOME DISCONNECTED FROM THE LUER CONNECTION. THIS DISCONNECTION PREVENTED THE GUIDE WIRE FROM FEEDING INTO THE GUIDE WIRE TUBE THROUGH TO THE CATHETER. ONCE THE GUIDE WIRE TUBE WAS RECONNECTED, THE GUIDE WIRE WAS ABLE TO PASS AND FEED INTO THE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WOULD NOT ALLOW PASSAGE OF A SCOPE. IT WAS ALSO REPORTED THAT NO PATIENT INJURY WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI VUECATH SPINAL ENDOSCOPIC SYSTEM ARTHROSCOPE HRX EBI, L.P. 11083

    Patients

    Seq Age Sex Outcome Treatment
    1