BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION BRONCHUS SYSTEM (SDBS)

    MDR report key: 1604035 · Received February 11, 2010

    Report

    Report Number
    3004962788-2010-00008
    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. IT WAS NOTED BY THE TECHNICAL FIELD SPECIALIST THAT THE BED POSITION WAS NOT THE SAME AS THE POSITION THE BED WAS ORIGINALLY MAPPED TO. THE PHYSICIAN WAS INFORMED THAT THE BED POSITION CAN NOT BE CHANGED FROM THAT POSITION UNLESS THE BED IS RE-MAPPED. THE PHYSICIAN STATED, HE UNDERSTOOD AND THE BED POSITION WAS PLACED BACK TO ITS ORIGINAL POSITION BEFORE THE NEXT CASE. THE SYSTEM WAS THEN TESTED FOR ACCURACY. THE ACCURACY TESTING DID NOT SHOW ANY PROBLEMS, THE TESTS WERE WITHIN SPECIFICATION. IN ADDITION, ON (B)(6) 2010, A SUPERDIMENSION ENGINEER WAS ON-SITE TO OBSERVE ADDITIONAL CASES. THERE WERE NO ACCURACY ISSUES AND THE SYSTEM PERFORMED AS EXPECTED. LABELING STATES THE FOLLOWING: "SIGNIFICANT CHANGES TO THE CONFIGURATION OF THE BRONCHOSCOPY SUITE, INCLUDING INTRODUCTION OF NEW METALLIC EQUIPMENT OR MOVEMENT OF EXISTING METALLIC EQUIPMENT CAN AFFECT THE ACCURACY OF THE SYSTEM. CONTACT SUPERDIMENSION CUSTOMER SERVICE TO SCHEDULE A RECALIBRATION OF THE INSTRUMENT PRIOR TO MAKING BRONCHOSCOPY SUITE RECONFIGURATIONS".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SUPERDIMENSION CASE, THE PHYSICIAN OBSERVED A DRIFT IN THE ACCURACY. INITIALLY THEY RECEIVED A 5.5MM REGISTRATION AND PROCEEDED TO NAVIGATE TO THE LYMPH NODE. ONCE NAVIGATION WAS COMPLETE, THEY MADE SEVERAL PASSES WITH A NEEDLE. WHEN THEY REINSERTED THE LG TO VERIFY POSITION THERE SEEMED TO HAVE BEEN A SHIFT IN IT'S POSITION. WHEN THEY RETURNED TO THE (B)(6), THE VISUAL VERIFICATION WAS OFF. THEY REREGISTERED THE PATIENT AND RECEIVED A 4.5MM VALUE. THEY PROCEEDED WITH THE REST OF THE CASE WITHOUT ISSUE. 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