BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONICS XOMED

    MDR report key: 446784 · Received March 5, 2003

    Report

    Report Number
    446784
    Event Type
    Malfunction
    Date Received
    March 5, 2003
    Date of Event
    February 28, 2003
    Report Date
    March 4, 2003
    Manufacturer
    MEDTRONIC XOMED, CUSTOMER LOYALITY DEPT.
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED TO OUTPATIENT SURGERY FOR ENDOSCOPIC FRONTOSPHENOID ETHMOIDECTOMY USING THE MEDTRONIC XOMED STEALTH IMAGE GUIDANCE SYSTEM. THE SYSTEM WAS SET-UP, TURNED ON AND UNDERSTOOD TO BE FUNCTIONAL. WHILE MAPPING THE SYSTEM, IT SHUT DOWN AND WOULD NOT WORK AGAIN. SALES REP WAS AVAILABLE IN THE OPERATING ROOM FOR TROUBLE SHOOTING FROM THE BEGINNING OF THE SURGICAL CASE. THE CO TELEPHONE SUPPORT LINE WAS ACTIVATED TO HELP SOLVE THE PROBLEM. THE PROBLEM WAS NOT SOLVED. THE PT ENDURED AN EXTRA 30 MINUTES OF ANESTHESIA DUE TO THE EQUIPMENT SHUTDOWN AND TROUBLE SHOOTING EFFORTS. THE PLANNED SURGICAL PROCEDURE USING THE STEALTH GUIDANCE SYSTEM HAD TO BE ABORTED SECONDARY TO THE BREAKDOWN OF THE EQUIPMENT. ACCORDING TO THE SURGEON, THE SURGICAL PROCEDURE WAS PERFORMED IN A LESS AGGRESSIVE MANNER DUE TO THE EQUIPMENT BEING NON-FUNCTIONAL. IT IS UNKNOWN AT THIS TIME WHETHER THE PT WILL HAVE TO RETURN FOR FURTHER SURGERY. THE MFR REPAIR STAFF ARRIVED 24 HOURS LATER AND FOUND THAT THE COMPUTER ASPECT OF THE NEWLY PURCHASED SYSTEM WAS NON-FUNCTIONAL. THE COMPUTER COMPONENT WAS REPLACED. THE SYSTEM IS UNDER MFR WARRANTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONICS XOMED STEALTH IMAGE GUIDANCE SYSTEM LLZ MEDTRONIC XOMED, CUSTOMER LOYALITY DEPT. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other