MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-09-28 for VISERA XENON LIGHT SOURCE CLV-S40 manufactured by Olympus Medical Systems Corp..
[55789744]
The subjected device was returned to olympus medical systems corp. (omsc) for evaluation. Omsc evaluated the device and found the following. - omsc could not find the signature of the electrical short circuit. - the dust was not deposited. - the lamp was attached without the slip. - the heat-compound was pasted properly. - the lamp gas was not leaked. - the lamp was turned on without any abnormality. - the standby mode could not be activated. - the brightness selector could not be activated. - the emergency lamp could not be turned on. - the lamp life meter could not be displayed. The clv-s40 instruction manual states the corresponding method when there is an abnormality. 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
[55789745]
Olympus was informed the following information. The user facility changed the layout with the moving of the hospital. The user facility mounted the subject device to the trolley until then. After the moving of the hospital, the user facility mounted the subject device to the ceiling pendant made by (b)(6). After that, the user facility turned on the subject device, and the white smoke occurred from the back of the lamp box of the subject device. The user facility turned off the subject device. There was no report of the patient's injury regarding this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2016-01249 |
| MDR Report Key | 5982365 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-09-28 |
| Date of Report | 2017-07-25 |
| Date of Event | 2016-08-31 |
| Date Mfgr Received | 2016-10-12 |
| Device Manufacturer Date | 2008-08-26 |
| Date Added to Maude | 2016-09-28 |
| 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. SUSUMU NISHINA |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 42 6425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISERA XENON LIGHT SOURCE |
| Generic Name | LIGHT SOURCE |
| Product Code | GCT |
| Date Received | 2016-09-28 |
| Returned To Mfg | 2016-09-06 |
| Model Number | CLV-S40 |
| 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 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-28 |