MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-03-11 for ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM 8065750290 manufactured by Alcon - Irvine Technology Ctr.
[16555297]
A customer reported a burned out lamp and a strong odor coming from the equipment during a vitrectomy procedure. They replaced the lamp and smoke started coming out of the equipment. The procedure was able to be completed following a ten minute delay for a system exchange. There was no harm to the pt.
Patient Sequence No: 1, Text Type: D, B5
[16606903]
The company rep examined the system and confirmed both system messages reported and noted that the lamp was burned. The power supply and lamp were replaced. The system was then tested and met all product specs. 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 not indicate any add'l similar reports for this system. The root cause cannot be determined conclusively. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028159-2013-00341 |
| MDR Report Key | 3001723 |
| Report Source | 01,05 |
| Date Received | 2013-03-11 |
| Date of Report | 2013-02-12 |
| Date of Event | 2013-02-11 |
| Date Mfgr Received | 2013-02-12 |
| Device Manufacturer Date | 2007-06-01 |
| Date Added to Maude | 2013-03-26 |
| 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 | ARTHUR CIOCIOLA |
| Manufacturer Street | 6201 SOUTH FREEWAY TC-40 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152442 |
| Manufacturer G1 | ALCON - IRVINE TECHNOLOGY CTR |
| 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 | 2013-03-11 |
| Model Number | NA |
| Catalog Number | 8065750290 |
| Lot Number | NA |
| ID Number | 1.18 |
| 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 | 2013-03-11 |