MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-01-04 for ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM 8065750290 manufactured by Alcon - Irvine Technology Center.
[3110969]
A customer reported that the equipment displayed a system message and locked prior to a vitreo-retinal procedure. The patient was in the surgical room and had received peribulbar anesthesia. There was no harm to the patient, but the procedure was cancelled.
Patient Sequence No: 1, Text Type: D, B5
[10352389]
The customer canceled the service request and stated the system was working. There was no sample returned for evaluation and no additional information 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 not indicate any additional similar reports for this system. The root cause was not able to be determined conclusively. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028159-2012-02061 |
| MDR Report Key | 2903601 |
| Report Source | 01,05 |
| Date Received | 2013-01-04 |
| Date of Report | 2012-12-06 |
| Date of Event | 2012-12-05 |
| Date Mfgr Received | 2012-12-06 |
| Device Manufacturer Date | 2010-05-01 |
| Date Added to Maude | 2013-01-29 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PAUL NITSCHMANN |
| Manufacturer Street | 6201 SOUTH FREEWAY, R3-16 |
| Manufacturer City | FORT WORTH TX 761343818 |
| Manufacturer Country | US |
| Manufacturer Postal | 761343818 |
| Manufacturer Phone | 8176152440 |
| Manufacturer G1 | ALCON - IRVINE TECHNOLOGY CENTER |
| Manufacturer Street | 15800 ALTON PKWY. |
| Manufacturer City | IRVINE CA 92618381 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 3818 |
| 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 | 2013-01-04 |
| Model Number | NA |
| Catalog Number | 8065750290 |
| Lot Number | NA |
| ID Number | 1.18 - 2.18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2013-01-04 |