MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,04,consumer,foreign,oth report with the FDA on 2015-05-14 for ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM 8065750290 manufactured by Alcon Research, Ltd. - Irvine Technology Center.
[5949224]
A medical assistant reported that the equipment required a lamp change prior to a surgical procedure. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[13361812]
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
[23183420]
The customer reported that the system required a lamp change. The reported event occurred before surgery. There was no patient impact. The company representative examined the system and replaced a lamp module assembly. The system was then tested and met all product specifications. The system was manufactured on september 13, 2006. Based on qa assessment, the product met specifications at the time of release. A review of complaints for the last 24 months did not indicate any additional related reports for this system. The root cause cannot be determined conclusively. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028159-2015-06014 |
| MDR Report Key | 4771705 |
| Report Source | 00,01,04,CONSUMER,FOREIGN,OTH |
| Date Received | 2015-05-14 |
| Date of Report | 2015-08-13 |
| Date of Event | 2015-04-17 |
| Date Mfgr Received | 2015-07-21 |
| Device Manufacturer Date | 2006-09-13 |
| Date Added to Maude | 2015-06-12 |
| 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 |
| Reporter Occupation | MEDICAL ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. EDDIE DARTON, MD, JD |
| Manufacturer Street | MAIL STOP AB2-6 MAIL STOP R3-48 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175686660 |
| Manufacturer G1 | ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER |
| Manufacturer Street | 15800 ALTON PARKWAY |
| 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 | 2015-05-14 |
| 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 | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER |
| Manufacturer Address | 15800 ALTON PARKWAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-05-14 |