D
Patient 1
A CUSTOMER REPORTED THAT THE LAMP OF THE EQUIPMENT TURNED ITSELF OFF DURING A VITREO-RETINAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER EQUIPMENT WITH NO HARM TO THE PT.
MAUDE MDR 2926945
- MDR report key
- 2926945
- Report number
- 2028159-2013-00072
- Event key
- 0
- Event type
- 3
- Date of event
- 2012-12-19
- Date received
- 2013-01-18
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 0
Manufacturer Contact#
- Contact
- PAUL NITSCHMANN
- Address
- 6201 SOUTH FREEWAY, R3-16 FORT WORTH TX 76134 US
- Phone
- 817-817-8176
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM | ENDOILLUMINATOR | ALCON - IRVINE TECHNOLOGY CENTER | MPA | NA | 8065750290 | NA | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-01-18 | 0 |
Event Narratives#
N
Patient 1
NO SERVICE HAS BEEN PERFORMED ON THE SYSTEM. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADD'L INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST (B)(4) DID INDICATE 1 SIMILAR REPORT FOR THIS SYSTEM. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).