MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-15 for VISERA ELITE XENON LIGHT SOURCE CLV-S190 manufactured by Olympus Medical Systems Corp..
[67708209]
The subject circuit board of the clv-s190 was returned to olympus for evaluation. Olympus replaced the circuit board of the spare clv-s190 with the subject circuit board and confirmed the spare clv-s190. The spare clv-s190 worked normally with the subject circuit board and there was no other abnormality found. There was no similar medical device report of clv-s190 in the past. There were no further details provided at this time. If significant additional information is received, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[67708210]
During the prostate plasma resection with the subject clv-s190, when the resectoscope was moved, the image of the monitor flashed. The user facility replaced the subject clv-s190 with the unspecified similar device to complete the procedure. There was no report of the patient injury other than replacing the device. When the field service engineer of olympus checked the subject clv-s190 at the branch office, the phenomenon was reproduced. The circuit board of the subject clv-s190 was replaced, and the circuit board was returned to olympus for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2017-00173 |
| MDR Report Key | 6331150 |
| Date Received | 2017-02-15 |
| Date of Event | 2016-11-04 |
| Date Mfgr Received | 2016-11-07 |
| Date Added to Maude | 2017-02-15 |
| 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 HIROKI MORIYAMA |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 8142642517 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VISERA ELITE XENON LIGHT SOURCE |
| Generic Name | XENON LIGHT SOURCE |
| Product Code | GCT |
| Date Received | 2017-02-15 |
| Returned To Mfg | 2017-01-06 |
| 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-TO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-15 |