FCR IMAGING PLATE

Description of Event or Problem

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.

Additional Manufacturer Narrative

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.