MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-18 for XENON LAMP MD-631 manufactured by Olympus Medical Systems Corp..
[83223028]
The subject md-631 was returned to olympus medical systems corp. (omsc) for evaluation. Omsc confirmed that the subject md-631 did not light up and the reported phenomenon could be reproduced. Omsc confirmed the crack on the glass part of the subject md-631. From above evaluation results, omsc surmised that the reported phenomenon was caused by leaking xenon gas of the subject md-631 from the crack. Omsc checked the device history record of the subject device, and there was no irregularity found. 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
[83223029]
At the final step of the esd, the subject md-631 in the clv-260 nbi did not light up and the emergency lamp lighted up. The user turned off and re-turned on the clv-260nbi, but the phenomenon was not solved. The user replaced the subject md-631 mounted in the clv-260nbi with a spare md-631 and completed the procedure. There was no report of the patient? S injury regarding this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2017-01214 |
| MDR Report Key | 6803064 |
| Date Received | 2017-08-18 |
| Date of Report | 2017-08-18 |
| Date of Event | 2017-07-26 |
| Date Mfgr Received | 2017-07-26 |
| Date Added to Maude | 2017-08-18 |
| 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 KATSUAKI MORITA |
| 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 | 0 |
| Brand Name | XENON LAMP |
| Generic Name | XENON LAMP |
| Product Code | GCT |
| Date Received | 2017-08-18 |
| Returned To Mfg | 2017-08-08 |
| Model Number | MD-631 |
| Lot Number | 6CBC2809 |
| ID Number | 04953170355950 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-18 |