MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-10-18 for ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM 8065750290 manufactured by Alcon - Irvine Technology Ctr.
[3083185]
A customer reported that during surgery, a system message displayed and the lamp was overly warm. The system was switched out to complete the case. There was no harm to the pt.
Patient Sequence No: 1, Text Type: D, B5
[10237910]
The company rep examined the sys and replaced the xenon lamp. Preventive maintenance was performed. The sys was then tested and met all product specifications. There was no sample returned for eval and no additional 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 24 months did indicate one similar report for this system. Since no sample has been returned for eval the root cause of the reported event cannot be determined conclusively. However, the most likely cause of the reported event can be attributed to a nonconforming xenon lamp. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028159-2012-01621 |
| MDR Report Key | 2801410 |
| Report Source | 01,05 |
| Date Received | 2012-10-18 |
| Date of Report | 2012-09-18 |
| Date of Event | 2012-09-18 |
| Date Mfgr Received | 2012-09-18 |
| Device Manufacturer Date | 2006-08-01 |
| Date Added to Maude | 2012-11-07 |
| 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 | PAUL NITSCHMANN |
| Manufacturer Street | 6201 S. FREEWAY R3-16 |
| Manufacturer City | FORTH WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152440 |
| 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 | 2012-10-18 |
| 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 CTR |
| Manufacturer Address | 15800 ALTON PKWY. IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-18 |