BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FCR IMAGING PLATE

    MDR report key: 4623233 · Received March 19, 2015

    Report

    Report Number
    2443168-2015-00001
    Event Type
    Injury
    Date Received
    March 19, 2015
    Date of Event
    September 11, 2014
    Report Date
    March 17, 2015
    Manufacturer
    FUJIFILM MEDICAL SYSTEM U.S.A., INC.
    Product Code
    IXW
    PMA / PMN Number
    K033561
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    FMSU EXAMINED THE SUBJECT IMAGING PLATE (IP) BOTH PHYSICALLY AND FUNCTIONALLY. A VISUAL EXAMINATION OF THE IP REVEALED A FINE LINE SCRATCH ON THE IP COATING STARTING FROM THE UPPER LEFT AND RUNNING INTO THE CENTER OF THE IP. SEE ATTACHMENT 1 FOR A PHOTOGRAPHIC IMAGE OF THE IP. ATTACHMENT 2 IS A COPY OF THE IMAGE TAKEN AT THE USER SITE. THE "WIRE" REPORTED BY THE USER IS CLEARLY SEEN IN THIS IMAGE. IT IS ALSO CLEAR FROM THIS IMAGE THAT THE LINE PURPORTED TO BE A WIRE EXTENDS BEYOND THE SKIN MARGIN AND SHOULD HAVE EVIDENCED ITSELF AS PROTRUDING FROM THE ARM. NOTE: THE LINE IS BEST VIEWED BY ZOOMING IN ON THE PHOTOGRAPHIC IMAGE.

    Description of Event or Problem · 1

    DURING A RECENT FDA INSPECTION OF FUJIFILM MEDICAL SYSTEMS, U.S.A., INC., (FMSU) IN (B)(6), IT WAS DETERMINED THAT THIS EVENT SHOULD HAVE BEEN REPORTED BY FMSU AS AN MDR. THIS EVENT WAS REPORTED VIA FORM 3500A RECEIVED FROM FDA (B)(6) 2014. (REPORT NO. 3900320000-2014-8001) THE EVENT IS DESCRIBED BY THE USER AS FOLLOWS: "A FOREIGN BODY (WIRE) WAS IDENTIFIED ON A PATIENT'S FOREARM X-RAY. FILM REVIEWED AND CONFIRMED BY RADIOLOGIST. APPROXIMATELY 2 WEEKS LATER, PATIENT WAS IN SURGERY AND SEDATED FOR SURGICAL INTERVENTION TO REMOVE WIRE. THE SURGEON WAS UNABLE TO LOCATE FOREIGN BODY UNDER FLUORO IN THE OPERATION ROOM. THE RAD TECH WHO WAS OPERATING THE FLUORO LOOKED THE IMAGES AND DISCOVERED THAT THE FOREIGN BODY THAT WAS IDENTIFIED WAS NOT A FOREIGN BODY. IT WAS A DEFECT ON THE X-RAY IMAGING PLATE. SURGERY WAS THEN ENDED. IMAGING PLATE WAS TAKEN OUT OF SERVICE. DEFECT ON IMAGING PLATE DID NOT APPEAR ON PREVIOUS FILMS. NO OTHER PATIENTS AFFECTED. DEFECT ON IMAGING PLATE WAS NOT VISIBLE DURING/PRIOR TO THIS PATIENT"S RADIOLOGICAL EXAM."FUJIFILM MEDICAL SYSTEMS U.S.A., INC. (FMSU) INITIALLY DID NOT BELIEVE THIS EVENT WAS REPORTABLE FOR THE FOLLOWING REASONS: THE DEVICE DID NOT MALFUNCTION. IT OPERATED AS INTENDED AND THE USER APPEARED NOT TO HAVE FOLLOWED INSTRUCTIONS REGARDING PERIODIC INSPECTION OF IMAGING PLATES. SEE ATTACHMENT C FOR A COPY OF FMSU'S "FCR IMAGING PLATE (IP) AND CASSETTE CARE AND MAINTENANCE" DOCUMENT, WHICH IS PROVIDED TO USERS. THE DEVICE DID NOT CAUSE AN INJURY. FMSU BELIEVES THAT IF, INDEED, THERE WAS A "WIRE" THE IMAGE RECEIVED FROM THE USER INDICATES THAT IT WOULD HAVE CROSS BEYOND THE SKIN AND WOULD HAVE BEEN PHYSICALLY VISIBLE. HOWEVER, FMSU DOES ACKNOWLEDGE THAT IT MAY HAVE BEEN A REPORTABLE EVENT WHEN CONSIDERING THAT THE PATIENT WAS ACTUALLY UNNECESSARILY PREPARED FOR SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187427 FCR IMAGING PLATE DIGITAL IMAGE DETECTOR IXW FUJIFILM MEDICAL SYSTEM U.S.A., INC. P/N 15189368 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other