MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2007-07-10 for REVLITE 661-0020 manufactured by Hoya Conbio.
[641235]
While a revlite laser system was being tested in manufacturing, a software bug was noted. The conditions are: when requesting the system change the output wavelength to be delivered and the user immediately presses the ready button, the system will go to the ready mode without changing the output wavelength to the one requested. This sequence of button presses must be done very quickly, and it is therefore unlikely to occur in normal use, however, it is possible for this to happen. The risk associated with this is the system will deliver the previous wavelength that was being used and the operator will have changed their eyewear to the requested wavelength. The attached risk analysis identifies the risk of each wavelength change combination.
Patient Sequence No: 1, Text Type: D, B5
[7907659]
This is a new product and only 14 systems are in the field, only 5 at end customer locations, 4 are prototypes which do not have the problem, 2 are in engineering, and the remaining 3 are in the hands of sales staff as demos. Upon disclosure of the problem all shipments were placed on hold. An advisory notice was prepared and sent to the end customers to notify them of the issue and instructed them how to operate the system in a safe manner. The sales staff was notified by email. A software upgrade was initiated to correct the problem and it will be available to the service department july 6 for installing in the installed base.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2918486-2007-00003 |
| MDR Report Key | 879117 |
| Report Source | 00 |
| Date Received | 2007-07-10 |
| Date of Report | 2007-06-29 |
| Date of Event | 2007-06-22 |
| Device Manufacturer Date | 2007-06-01 |
| Date Added to Maude | 2008-02-01 |
| 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 BOULEVARD |
| 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 | ND: YAG Q-SWITCHED LASER SYSTEM |
| Product Code | LXS |
| Date Received | 2007-07-10 |
| Catalog Number | 661-0020 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 956839 |
| Manufacturer | HOYA CONBIO |
| Manufacturer Address | FREMONT CA 94538 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-07-10 |