MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-02-18 for ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM 8065750290 manufactured by Alcon - Irvine Technology Center.
[21763807]
A customer reported that the system turned off on its own during a vitrectomy procedure. After a more than 15 minute delay, the procedure was completed with no harm to the pt.
Patient Sequence No: 1, Text Type: D, B5
[21892057]
A review of the service report indicates the system shuts down on its own. The company rep examined the system. The company rep cleaned the air filter and the air pathways. The system was then tested and met all product specifications. There was no sample returned for eval and no additional information provided related to this event. For this reason, steps could not be taken to replicate of confirm the reported event. A review of complaints for the last 24 months did indicate one similar report for this system. The root cause cannot be determined conclusively. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028159-2013-00227 |
| MDR Report Key | 2976619 |
| Report Source | 01,05 |
| Date Received | 2013-02-18 |
| Date of Report | 2013-01-25 |
| Date of Event | 2013-01-23 |
| Date Mfgr Received | 2013-01-25 |
| Device Manufacturer Date | 2006-08-01 |
| Date Added to Maude | 2013-03-12 |
| 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 | TERRY DAGNON |
| Manufacturer Street | 6201 SOUTH FREEWAY R7-18 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175514325 |
| Manufacturer G1 | ALCON - IRVINE TECHNOLOGY CENTER |
| Manufacturer Street | 15800 ALTON PKWY. |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM |
| Generic Name | ENDOILLUMINATOR |
| Product Code | MPA |
| Date Received | 2013-02-18 |
| Model Number | NA |
| Catalog Number | 8065750290 |
| Lot Number | NA |
| ID Number | 1.18 - 2.18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON - IRVINE TECHNOLOGY CENTER |
| Manufacturer Address | 15800 ALTON PKWY. IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-18 |