FDA Adverse Event
Malfunction
Summary report: N
DIGITAL RETINAL CAMERA CF-1
MDR report key: 2980290
·
Received January 28, 2013
Report
- Report Number
- 1000181430-2013-00012
- Event Type
- Malfunction
- Date Received
- January 28, 2013
- Report Date
- August 12, 2010
- Manufacturer
- CANON, INC
- Product Code
- HKI
- PMA / PMN Number
- K063717
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 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 REP FOUND THAT THE QUICK RETURN MIRROR SPRING FELL OFF. THE SPRING WAS REPLACED AND THE UNIT WAS OPERATING FINE. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE QUICK RETURN MIRROR DID NOT WORK. THE CUSTOMER DID NOT STATE WHEN THE PROBLEM OCCURRED DURING THE EXAM. HOWEVER, IF THE PROBLEM OCCURRED DURING THE FLUORESCEIN IMAGING PORTION OF THE EXAM, THE TECH MAY HAVE RESCHEDULED THE EXAM. A RESCHEDULED EXAM WOULD HAVE INVOLVED A REPEAT INJECTION OF FLUORESCEIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 38520 | DIGITAL RETINAL CAMERA CF-1 | HKI | CANON, INC | CF-1 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |