FDA.reportPublic FDA data

MAUDE MDR 2980369

MDR report key
2980369
Report number
1000181430-2013-00028
Event key
0
Event type
3
Date received
2013-01-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MR. NAOYASU ASAKA, MANAGER
Address
30-2 SHIMOMARUKO, 3-CHOME OHTA-KU, TOKYO 146-8 JA
Phone
375-375-3758
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DIGITAL RETINAL CAMERA CX-1CANON INC.NFJCX-13940B008AANAY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-01-280

Event Narratives#

D

Patient 1

THE CUSTOMER REPORTED THAT THERE WERE CIRCULAR SHADOWS ON THE LEFT SIDE OF THE IMAGES. NO INFORMATION WAS PROVIDED REGARDING WHAT IMAGE TYPES (COLOR, RED-FREE, FLUORESCEIN ANGIOGRAPHY) WERE AFFECTED. THE CUSTOMER DID NOT STATE THAT THE FLUORESCEIN IMAGING WAS REPEATED. HOWEVER, IF THE PROBLEM OCCURRED DURING THE FLUORESCEIN IMAGING PORTION OF THE EXAM, THE TECHNICIAN MAY HAVE RESCHEDULED THE EXAM. A RESCHEDULED EXAM WOULD HAVE INVOLVED A REPEAT INJECTION OF FLUORESCEIN.

N

Patient 1

THIS MDR IS BEING SUBMITTED RETROACTIVELY AS A RESULT OF AN INTERNAL AUDIT OF COMPLAINT FILES CONDUCTED BY CANON HEALTHCARE SOLUTIONS USA. (B)(4). THE SERVICE ENGINEER REPLACED THE SPLIT PRISM ASSEMBLY. HE ADJUSTED THE OD CALIBRATION AND CHECKED THE OPTICAL SYSTEM. THE SYSTEM WAS TESTED FOR PERFORMANCE. (B)(4).