BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION INREACH SYSTEM

    MDR report key: 3193177 · Received June 25, 2013

    Report

    Report Number
    3004962788-2013-00019
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    February 19, 2013
    Report Date
    June 25, 2013
    Manufacturer
    SUPERDIMENSION, INC.
    Product Code
    JAK
    PMA / PMN Number
    K081379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROCEDURE RECORDING EVALUATION FOUND LARGE LOCATABLE GUIDE ERRORS THAT RESULTED IN MULTIPLE REGISTRATION ATTEMPTS. THE EVALUATION SURMISES THAT THE REGISTRATION FAILURES WERE DUE TO A LOCATABLE GUIDE FAILURE; HOWEVER, THE SITE DID NOT RETURN A LOCATABLE GUIDE FOR EVALUATION. DURING THE PREVENTIVE MAINTENANCE VISIT, NEW MAPPING WAS PERFORMED AND THE SYSTEM PASSED ACCURACY TESTING. SUPERDIMENSION IS FILING THIS MDR IN AN ABUNDANCE OF CAUTION DUE TO THE RISKS ASSOCIATION WITH MULTIPLE EXPOSURES.

    Description of Event or Problem · 1

    SITE REPORTED DIFFICULTY WITH REGISTRATION WHILE USING THE SUPERDIMENSION SYSTEM DURING A CASE ON (B)(6) 2013 BUT DID NOT REPORT IT TO SUPERDIMENSION UNTIL A PREVENTIVE MAINTENANCE VISIT ON (B)(6) 2013. THE SUPERDIMENSION PORTION OF THE CASE WAS CANCELLED AND THE PT WAS UNDER GENERAL ANESTHESIA. THERE WAS NO REPORT OF PT INJURY, DEATH OR OTHER SERIOUS ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287237 SUPERDIMENSION INREACH SYSTEM ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY JAK SUPERDIMENSION, INC. AAS00016-03

    Patients

    Seq Age Sex Outcome Treatment
    1