BEUDAMED
    FDA Adverse Event Other Summary report: N

    ISITE RADIOLOGY

    MDR report key: 614090 · Received June 14, 2005

    Report

    Report Number
    2954704-2005-00002
    Event Type
    Other
    Date Received
    June 14, 2005
    Report Date
    June 1, 2005
    Manufacturer
    STENTOR, INC.
    Product Code
    LLZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED FROM USER FACILITY THAT AN IMAGE PRINTED WAS USED AS A 1:1 OR LIFE SIZE IMAGE IN PRE-SURGERY PLANNING. THE IMAGE WAS NOT PRINTED 1:1 RESULTING IN REPORTED ERROR DURING ORTHOPEDIC SURGERY WHICH COULD HAVE CLINICAL CONSEQUENCE. SINCE STENTOR HAS BEEN UNABLE TO RECEIVE FURTHER INFORMATION FROM THE FACILITY, AND THE ACTUAL FILM USED FOR PRE-SURGERY PLANNING IS UNAVAILABLE FOR REVIEW, STENTOR IS UNABLE TO DETERMINE WHETHER OR NOT THE ISITE PRODUCT WAS INVOLVED. UPON FACILITY VISIT IT WAS DISCOVERED THAT THE PRINT SETUP WAS MISCONFIGURED BY USER AND THUS POSSIBILITY OF INCORRECT PRINT DID EXIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISITE RADIOLOGY PICTURE ARCHIVING AND COMMUNICATION LLZ STENTOR, INC. V3.2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other