FDA Adverse Event
Malfunction
Summary report: N
ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM
MDR report key: 2020565
·
Received February 10, 2011
Report
- Report Number
- 2028159-2011-00084
- Event Type
- Malfunction
- Date Received
- February 10, 2011
- Date of Event
- January 7, 2011
- Report Date
- January 10, 2011
- Manufacturer
- ALCON- IRVINE TECHNOLOGY CENTER
- Product Code
- MPA
- PMA / PMN Number
- K951627
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A NURSE REPORTED THAT THE LIGHT FROM THE ILLUMINATOR SYSTEM WAS TURNING OFF INTERMITTENTLY DURING A VITRECTOMY PROCEDURE. THE LIGHT ON THE CONSOLE SYSTEM WAS USED TO COMPLETE THE SURGERY. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM | ENDOILLUMINATOR | MPA | ALCON- IRVINE TECHNOLOGY CENTER | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |