BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION BRONCHUS SYSTEM (SDBS)

    MDR report key: 1509321 · Received October 7, 2009

    Report

    Report Number
    3004659744-2009-00030
    Event Type
    Malfunction
    Date Received
    October 7, 2009
    Date of Event
    September 8, 2009
    Report Date
    October 7, 2009
    Manufacturer
    SUPERDIMENSION, LTD.
    Product Code
    JAK
    PMA / PMN Number
    K042438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN ON-SITE VISIT WAS PERFORMED ON (B)(6) 2009, AND IT WAS DISCOVERED THAT THE SITE WAS USING A MATTRESS THAT WAS ANTI-STATIC AND CONTAINED CONDUCTIVE MATERIAL WHICH IS NOT COMPATIBLE WITH THE SUPERDIMENSION SYSTEM. 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

    THE PHYSICIAN OBSERVED AND REPORTED A 14 MM INACCURACY IN THE REGISTRATION PHASE THAT DID NOT ALLOW CONTINUING TO THE NAVIGATION PHASE AND THEREFORE, THE PROCEDURE WAS ABORTED USING THE SUPERDIMENSION SYSTEM. THERE WAS NO HARM OR INJURY TO THE PT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1