BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIOBE MAGNETIC NAVIGATION SYSTEM

    MDR report key: 1458541 · Received August 31, 2009

    Report

    Report Number
    3003084417-2009-00002
    Event Type
    Injury
    Date Received
    August 31, 2009
    Date of Event
    August 26, 2009
    Report Date
    August 31, 2009
    Manufacturer
    STEREOTAXIS, INC.
    Product Code
    DXX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVOLVED A STAFF MEMBER (NOT THE PATIENT). THE ACCOUNT HAS AN MRI COMPATIBLE PORTABLE X-RAY SHIELD, AND IT WAS PULLED OUT OF THE MAGNETIC ROOM AND USED IN ANOTHER ROOM. A NON MRI COMPATIBLE SHIELD WAS BROUGHT INTO THE MAGNETIC ROOM FOR THE ANESTHESIOLOGIST TO USE. DURING THE PROCEDURE, THE X-RAY SHIELD BECAME ATTRACTED TO THE MAGNET, AND THE ANESTHESIOLOGIST TRIED TO STOP THE MOTION TOWARD THE MAGNETIC POD. AT THIS POINT HER RIGHT PINKY FINGER BECAME WEDGED BETWEEN THE SHIELD AND THE MAGNET, AND SHE SUFFERED TISSUE LOSS AT THE TIP OF HER PINKY FINGER AS WELL AS LOSS OF HER FINGERNAIL. SHE WAS TAKEN TO ER BY THE STAFF AND FOLLOWED UP WITH PLASTIC SURGEON. SHE WAS TOLD THAT SHE WOULD NOT BE ABLE TO REGROW HER FINGERNAIL, AND THE TIP OF HER FINGER WAS REPAIRED.

    Description of Event or Problem · 1

    INVOLVED A STAFF MEMBER (NOT THE PATIENT). THE ACCOUNT HAS AN MRI COMPATIBLE PORTABLE X-RAY SHIELD AND IT WAS PULLED OUT OF THE MAGNETIC ROOM AND USED IN ANOTHER ROOM. A NON MRI COMPATIBLE SHIELD WAS BROUGHT INTO THE MAGNETIC ROOM FOR THE ANESTHESIOLOGIST TO USE. DURING THE PROCEDURE, THE X-RAY SHIELD BECAME ATTRACTED TO THE MAGNET AND THE ANESTHESIOLOGIST TRIED TO STOP THE MOTION TOWARD THE MAGNETIC POD. AT THIS POINT HER RIGHT PINKY FINGER BECAME WEDGED BETWEEN THE SHIELD AND THE MAGNET, AND SHE SUFFERED TISSUE LOSS AT THE TIP OF HER PINKY FINGER AS WELL AS LOSS OF HER FINGERNAIL. SHE WAS TAKEN TO THE ER BY THE STAFF AND FOLLOWED UP WITH PLASTIC SURGEON. SHE WAS TOLD THAT SHE WOULD NOT BE ABLE TO REGROW HER FINGERNAIL AND THE TIP OF HER FINGER WAS REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIOBE MAGNETIC NAVIGATION SYSTEM STEERABLE CATHETER CONTROL SYSTEM DXX STEREOTAXIS, INC. 001-006000-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other