MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2009-03-02 for REVLITE 661-0025 manufactured by Hoya Conbio.
[22050589]
It was not necessary to return the system to be evaluated. The eval was performed on an equivalent system at the factory, the anomaly duplicated and then corrected with software upgrade. A notification letter is being sent to the affected users to inform them of the anomaly and how to safely use the system until their software can be upgraded in the field.
Patient Sequence No: 1, Text Type: N, H10
[22104600]
While the laser was being tested at the (b)(6), the technician observed that the laser was emitting 532nm wavelength energy but the control panel indicated that 1064nm was selected. There was no injury involved and there are no reports of this occurring at any customer facilities. A risk analysis was performed to determine the possible outcomes of this anomaly and it was determined that the risk was minor and the worst case would be the potential for minor blistering of the skin. There is no risk of eye injury because the normal eyewear used in dual wavelength and the dye hand piece would block the 1064nm wavelength if they are in use. An advisory letter is being sent to the current users that are affected that describes the anomaly and how the system can be in stalled. The software has been corrected, tested and released and the service department will install the upgrade as soon as possible.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2918486-2009-00001 |
| MDR Report Key | 1375624 |
| Report Source | 01,07 |
| Date Received | 2009-03-02 |
| Date of Report | 2009-02-24 |
| Date of Event | 2009-01-26 |
| Date Mfgr Received | 2009-01-26 |
| Device Manufacturer Date | 2008-12-01 |
| Date Added to Maude | 2010-05-05 |
| 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 Street | 47733 FREMONT BLVD. |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal | 94538 |
| Manufacturer Phone | 5104454528 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REVLITE |
| Generic Name | REVLITE Q-SWITCHED ND:YAG LASER SYSTEM |
| Product Code | LXS |
| Date Received | 2009-03-02 |
| Model Number | REVLITE |
| Catalog Number | 661-0025 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOYA CONBIO |
| Manufacturer Address | FREMONT CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-03-02 |