BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNAPSE

    MDR report key: 2996784 · Received March 6, 2013

    Report

    Report Number
    2443168-2013-00001
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    January 15, 2013
    Report Date
    February 25, 2013
    Manufacturer
    FUJIFILM MEDICAL SYSTEM U.S.A., INC.
    Product Code
    LLZ
    PMA / PMN Number
    K051553
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A RADIOLOGIST LAUNCHED AN ABDOMEN STUDY OF A (B)(6) AND WAS INTERRUPTED WHILE DICTATING. HE WAS REQUESTED TO REVIEW A SECOND ABDOMEN STUDY, THIS ONE OF A (B)(6) PATIENT ((B)(6)). WHEN THE RADIOLOGIST RETURNED TO COMPLETE HIS DICTATION OF PATIENT (B)(6)'S CASE, PATIENT (B)(6)'S IMAGES WERE STILL BEING DISPLAYED AND THE RADIOLOGIST COMPLETED HIS DICTATION OF PATIENT AGAINST PATIENT (B)(6)'S IMAGES. AS A CONSEQUENCE, PATIENT (B)(6) UNDERWENT AN UNNECESSARY SURGICAL PROCEDURE, I.E., APPENDECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95396 SYNAPSE PICTURE ARCHIVING AND COMMUNICATION SYST LLZ FUJIFILM MEDICAL SYSTEM U.S.A., INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO Other