BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION BRONCHUS SYSTEM (SDBS)

    MDR report key: 1522238 · Received October 27, 2009

    Report

    Report Number
    3004659744-2009-00031
    Event Type
    Malfunction
    Date Received
    October 27, 2009
    Date of Event
    September 30, 2009
    Report Date
    October 28, 2009
    Manufacturer
    SUPERDIMENSION, LTD.
    Product Code
    JAK
    PMA / PMN Number
    K042438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN ON-SITE VISIT WAS PERFORMED ON OCTOBER 19 AND 20, 2009. DURING THE ON-SITE VISIT THE SYSTEM PERFORMED WITHIN SPEC. IN ADDITION, 2 LOCATABLE GUIDES (LG'S) WERE RETURNED TO SUPERDIMENSION FOR A PRECAUTIONARY ANALYSIS. BOTH LG'S WERE TESTED AND WERE ALSO WITHIN SPECS. THE ERROR MESSAGE INDICATES THE PHYSICIAN WAS NOT MARKING THE SAME REGISTRATION POINTS IN THE PT AS WERE MARKED DURING PLANNING. THE PROCEDURE IS TYPICALLY PERFORMED UNDER LOCAL ANESTHESIA. HOWEVER, BASED ON THE ERROR MESSAGES PROVIDED BY THE SYSTEM, THE PROCEDURE WAS DISCONTINUED, BY THE PHYSICIAN, WITH THE PT UNDER GENERAL ANESTHESIA. IN AN ABUNDANCE OF CAUTION, THIS EVENT IS BEING REPORTED DUE TO THE ADD'L POTENTIAL RISK ASSOCIATED WITH MULTIPLE EXPOSURE TO GENERAL ANESTHESIA. THERE WAS NO INJURY TO THE PT REPORTED.

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED TO REGISTER THE PT MULTIPLE TIMES AND ALWAYS REC'D THE ERROR MESSAGE STATING "SOME OF THE REGISTRATION POINTS YOU HAVE ACQUIRED ARE MISMATCHED WITH THE POINTS PREVIOUSLY MARKED IN THE PLANNING PHASE. PLEASE VERIFY THAT THE POINTS HAVE BEEN ACQUIRED CORRECTLY, AND RE-ACQUIRE ALL POINTS IF POSSIBLE." THE SITE SWAPPED THE LOCATABLE GUIDE, BUT THIS DID NOT HELP, THEY CONTINUED TO RECEIVE THE ERROR MESSAGE. THEREFORE, THE PROCEDURE WAS CANCELLED WITH THE PT 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