MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2013-01-28 for DIGITAL RETINAL CAMERA CX-1 3940B008AA manufactured by Canon, Inc..
[3282690]
The customer reported that there was a shadow on the left side of the image. The problem appears intermittently in fluorescein imaging mode only. The customer did not mention that they had to re-inject the pt with fluorescein or reschedule the pt exam. However, the info suggests that a repeat injection may have been necessary during the exam, or a rescheduled exam, due to the shadow on the image.
Patient Sequence No: 1, Text Type: D, B5
[10582683]
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 dealer svc rep replaced the exposure switch unit. The system is working fine now. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000181430-2013-00025 |
| MDR Report Key | 2945792 |
| Report Source | 00,01 |
| Date Received | 2013-01-28 |
| Date of Report | 2011-08-01 |
| Date Mfgr Received | 2011-08-01 |
| Device Manufacturer Date | 2007-11-01 |
| Date Added to Maude | 2013-02-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. NAOYASU ASAKA, MGR. |
| Manufacturer Street | 30-2, SHIMOMARUKO, 3-CHOME OHTA-KU |
| Manufacturer City | TOKYO 146-8501 |
| Manufacturer Country | JA |
| Manufacturer Postal | 146-8501 |
| Manufacturer Phone | 37582111 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIGITAL RETINAL CAMERA CX-1 |
| Product Code | NFJ |
| Date Received | 2013-01-28 |
| Model Number | CX-1 |
| Catalog Number | 3940B008AA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CANON, INC. |
| Manufacturer Address | TOKYO 146-8501 146-8501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-01-28 |