BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION BRONCHUS SYSTEM (SDBS)

    MDR report key: 1604036 · Received February 11, 2010

    Report

    Report Number
    3004962788-2010-00009
    Event Type
    Malfunction
    Date Received
    February 11, 2010
    Date of Event
    January 15, 2010
    Report Date
    February 11, 2010
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPERDIMENSION TECHNICAL FIELD SPECIALIST WAS ON-SITE AT THE TIME OF THIS CASE TO OBSERVE. AFTER THE CASE, THE SYSTEM WAS TESTED FOR ACCURACY. THE ACCURACY TESTING DID NO SHOW ANY PROBLEMS, THE TESTS WERE WITHIN SPECIFICATION. IN ADDITION, ON JANUARY 19, 2010, A SUPERDIMENSION ENGINEER WAS ON-SITE TO OBSERVE ADDITIONAL CASES. THERE WERE NO ACCURACY ISSUES AND THE SYSTEM PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SUPERDIMENSION CASE, THE FIRST ATTEMPT AT REGISTRATION YIELDED A 13.9MM VALVE (<10MM IS THE SPECIFICATION) AND THE SYSTEM SUGGESTED TO REACQUIRE THE MC. AFTER DOING SO, THE VALUE INCREASED TO 14.5MM AND SUGGESTED TO REDO THE RIGHT UPPER LOBE AND RIGHT MIDDLE LOBE. THEY FOLLOWED THE INSTRUCTIONS BUT THIS TIME RECEIVED A MISMATCHED POINTS ERROR. THEY PROCEEDED TO DELETE ALL POINTS AND REREGISTER TWICE MORE, BUT STILL RECEIVED A MISMATCHED POINTS ERROR EACH TIME. AT THIS POINT, THEY CANCELLED THE SUPERDIMENSION PORTION OF THE PROCEDURE AND CONTINUED BY OTHER MEANS. THE PATIENT WAS UNDER GENERAL ANESTHESIA FOR THE CASE. THERE WAS NO HARM OR INJURY TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERDIMENSION BRONCHUS SYSTEM (SDBS) COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK SUPERDIMENSION INC.

    Patients

    Seq Age Sex Outcome Treatment
    1