MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-04-27 for VISERA ELITE XENON LIGHT SOURCE CLV-S190 manufactured by Olympus Medical Systems Corp..
[43843710]
The subject device was returned to olympus for evaluation. Olympus checked the subject device, and there was no abnormality of the subject device. The cause of this defect was not conclusively determined at this time. The cause was presumably attributed to following 2 items since the device worked properly once the facility turned on the device again. The device did not work when there was abnormal power supply environment temporarily in the facility. The safety mechanism worked because of rising internal temperature in the device. Olympus also checked the device history record of the subject device, there was no irregularity found. There were no further details provided at this time. If significant additional information is received, this report will be supplemented. Olympus stated the appropriate handling of the subject device in the instruction manual when the subject device had abnormalities.
Patient Sequence No: 1, Text Type: N, H10
[43843711]
Olympus was informed that the examination lamp of the subject device went off and the error code (e102) was shown to a monitor during the reconstructive operation of biliary tract. The examination lamp of the subject device lit up once the facility turned on the device again. However, the facility converted the procedure to an open surgery, because the facility was alarmed. The open surgery was completed. There was no report of the patient's injury regarding this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2016-00599 |
| MDR Report Key | 5613216 |
| Report Source | USER FACILITY |
| Date Received | 2016-04-27 |
| Date of Report | 2016-04-28 |
| Date of Event | 2016-04-05 |
| Date Mfgr Received | 2016-04-05 |
| Device Manufacturer Date | 2014-11-05 |
| Date Added to Maude | 2016-04-27 |
| 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 ELITE XENON LIGHT SOURCE |
| Generic Name | LIGHT SOURCE |
| Product Code | GCT |
| Date Received | 2016-04-27 |
| Returned To Mfg | 2016-04-12 |
| Model Number | CLV-S190 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 1. Hospitalization; 2. Other | 2016-04-27 |