BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION INREACH SYSTEM

    MDR report key: 3042562 · Received April 4, 2013

    Report

    Report Number
    3004962788-2013-00009
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    March 8, 2013
    Report Date
    April 4, 2013
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    PMA / PMN Number
    K092365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUPERDIMENSION IS THE PROCESS OF RETRIEVING PROCEDURE RECORDINGS FOR EVALUATION. SUPERDIMENSION IS FILING THIS MDR IN AN ABUNDANCE OF CAUTION DUE TO THE RISKS ASSOCIATED WITH MULTIPLE EXPOSURES TO ANESTHESIA.

    Description of Event or Problem · 1

    SITE REPORTED THEY WERE NOT ABLE TO GET THE SUPERDIMENSION SYSTEM TO NAVIGATE TO A TARGET DURING A CASE. THE SUPERDIMENSION PORTION OF THE CASE WAS CANCELLED AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. THERE WAS NO REPORT OF PATIENT INJURY, DEATH OR OTHER SERIOUS ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138525 SUPERDIMENSION INREACH SYSTEM ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY JAK SUPERDIMENSION INC. AA500161-12

    Patients

    Seq Age Sex Outcome Treatment
    1