MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-16 for XENON LAMP MD-631 manufactured by Olympus Medical Systems Corp..
[145222643]
The subject md-631 was not returned to olympus medical systems corp. (omsc) for evaluation yet. Omsc investigate the subject md-631 to determine the cause of this phenomenon when omsc receives it. There were no further details provided. If significant additional information is received, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[145222644]
During the unspecified procedure with the operation microscope ome-8000 and the xenon light ome8-slx using the xenon lamp md-631, the subject md-631 went off. The user replaced the subject md-631 with another xenon lamp to complete the procedure. There was no report of the patient injury other than replacing the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2019-01946 |
| MDR Report Key | 8614656 |
| Date Received | 2019-05-16 |
| Date of Report | 2019-07-19 |
| Date of Event | 2019-04-18 |
| Date Mfgr Received | 2019-06-26 |
| Date Added to Maude | 2019-05-16 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR KAZUTAKA MATSUMOTO |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 426425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XENON LAMP |
| Generic Name | XENON LAMP |
| Product Code | GCT |
| Date Received | 2019-05-16 |
| Model Number | MD-631 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-16 |