FCR IMAGING PLATE P/N 15189368 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-03-19 for FCR IMAGING PLATE P/N 15189368 NA manufactured by Fujifilm Medical System U.s.a., Inc..

Event Text Entries

[19800937] 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.
Patient Sequence No: 1, Text Type: D, B5


[20141248] 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.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2443168-2015-00001
MDR Report Key4623233
Report Source06
Date Received2015-03-19
Date of Report2015-03-17
Date of Event2014-09-11
Date Mfgr Received2014-11-03
Date Added to Maude2015-03-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactARYE HESS
Manufacturer Street419 WEST AVE.
Manufacturer CitySTAMFORD CT 06902
Manufacturer CountryUS
Manufacturer Postal06902
Manufacturer Phone2036023652
Manufacturer G1FUJIFILM MEDICAL SYSTEM U.S.A., INC.
Manufacturer Street798 MIYANODAI
Manufacturer CityKAISEI-MACHI, ASHIGARAKAMI-GUN, KANAGAWA
Manufacturer CountryJA
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFCR IMAGING PLATE
Generic NameDIGITAL IMAGE DETECTOR
Product CodeIXW
Date Received2015-03-19
Returned To Mfg2014-12-19
Model NumberP/N 15189368
Catalog NumberNA
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerFUJIFILM MEDICAL SYSTEM U.S.A., INC.
Manufacturer Address798 MIYANODAI KAISEI-MACHI, ASHIGARAKAMI-GUN, KANAGAWA JA


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-03-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.