BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION BRONCHUS SYSTEM (SDBS)

    MDR report key: 1357644 · Received March 26, 2009

    Report

    Report Number
    3004659744-2009-00009
    Event Type
    Malfunction
    Date Received
    March 26, 2009
    Date of Event
    February 27, 2009
    Report Date
    March 26, 2009
    Manufacturer
    SUPERDIMENSION, LTD.
    Product Code
    JAK
    PMA / PMN Number
    K042438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPONENT OF THE SUPERDIMENSION SYSTEM, THE PT SENSOR TRIPLET (PST) WAS REMOVED FROM THE SYSTEM AND REPLACED. THE CUSTOMER RECEIVED A NEW PT SENSOR TRIPLET AS A REPLACEMENT. AT THIS TIME, SUPERDIMENSION HAS NOT YET RECEIVED AND OR PROCESSED THE RETURN. IN 2009, IT WAS REPORTED FROM THE SITE THAT THE SYSTEM SEEMS TO BE FUNCTIONING PROPERLY NOW.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT HE WAS ABLE TO REACH AND BIOPSY THE FIRST LESION. HOWEVER, THE PHYSICIAN REPORTED THAT HE THEN TRIED TO ACCESS A SECOND LESION BUT WAS NOT ABLE TO REACH IT DUE TO SYSTEM INACCURACY. THEREFORE, THE CASE WAS ABANDONED. THE PT WAS UNDER GENERAL ANESTHESIA. 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