BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION BRONCHUS SYSTEM

    MDR report key: 2438587 · Received January 13, 2012

    Report

    Report Number
    3004962788-2012-00002
    Event Type
    Malfunction
    Date Received
    January 13, 2012
    Date of Event
    December 14, 2011
    Report Date
    January 13, 2012
    Manufacturer
    SUPERDIMENSION, INC
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RECEIVED FOR EVALUATION TO DATE. THERE WAS NO HARM OR INJURY TO THE PT REPORTED. IN AN ABUNDANCE OF CAUTION, WE ARE FILING THIS MDR BECAUSE OF THE ADDITIONAL RISK ASSOCIATED WITH MULTIPLE EXPOSURES TO GENERAL ANESTHESIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE DIFFICULTIES WITH THE VISUAL VERIFICATION DURING AUTO REGISTRATION WITH THE SUPERDIMENSION SYSTEM. WHEN ATTEMPTING TO RETRY REGISTRATION, THE "LADDER" ON THE SCOPE BROKE AND THE PROCEDURE WAS TERMINATED. THE SCOPE IS NOT A SUPERDIMENSION PRODUCT. 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 COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK SUPERDIMENSION, INC AAS00161-12

    Patients

    Seq Age Sex Outcome Treatment
    1