MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-09-23 for ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM 8065750290 manufactured by Alcon - Irvine Technology Center.
[2977589]
A customer reported that illumination was poor during a vitrectomy procedure. The procedure was able to be completed using an alternate illumination system with no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
[10139626]
The company representative examined the system and was able to confirm the reported event. The company representative replaced the lamp module assembly. The system was then tested and met all product specifications. A review of complaints for the last 24 months did indicate 1 similar report for this system. The root cause of the reported event could have been a nonconforming lamp, as the company representative replaced the lamp and the nonconformity was resolved. A sample has been received but has not yet been evaluated. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028159-2012-01442 |
| MDR Report Key | 2759510 |
| Report Source | 01,05 |
| Date Received | 2012-09-23 |
| Date of Report | 2012-08-22 |
| Date of Event | 2012-08-10 |
| Date Mfgr Received | 2012-08-22 |
| Device Manufacturer Date | 2006-09-01 |
| Date Added to Maude | 2012-11-14 |
| 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 SOUTH FREEWAY R3-16 |
| Manufacturer City | FORT 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 | 2012-09-23 |
| Returned To Mfg | 2012-09-14 |
| Model Number | NA |
| Catalog Number | 8065750290 |
| Lot Number | NA |
| ID Number | UNK |
| 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 | 2012-09-23 |