MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-07-14 for OLYMPUS VISERA PRO XENONLIGHT SOURCE CLV-S40PRO manufactured by Olympus Medical Systems Corp..
[49500205]
The subject device was returned to olympus for evaluation. The evaluation of olympus confirmed the failure of the subject device of the user's report. The subject device was the following condition. Dust was collecting in the ventilation grills and the fan of the subject device. The fuse in the subject device had been blown. The voltage value and the current value of the subject device were normal. After the olympus exchanged the fuse of the subject device, the subject device worked properly. The cause of this defect was not conclusively determined at this time. The cause was presumably attributed to following 3 items since the subject device worked properly after the olympus exchanged the fuse of the subject device. It is considered accidental failure since the above condition of clv-s40pro doesn't occur the past 5 years. The temperature inside the subject device became high because dust collected in the subject device. Therefore the fuse was blown by a temporary over-current due to thermal runaway of the elements. The fuse was blown by over-current due to temporary short circuit at high voltage part. The fuse was blown by degradation of the fuse due to a long time of use (about 8 years). Clv-s40pro instruction manual states the notice for the handling of the device. 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
[49500206]
During the laparoscopic myomectomy for fibroids, the subject clv-s40pro was turned off suddenly. The user investigated the power cable and the switch of isolation transformer, but the situation did not change. The user completed the procedure with replacing the subject clv-s40pro to another clv-s40pro. There was no report of the patient injury other than replacing the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2016-00931 |
| MDR Report Key | 5793525 |
| Report Source | USER FACILITY |
| Date Received | 2016-07-14 |
| Date of Report | 2016-07-14 |
| Date of Event | 2016-06-16 |
| Date Mfgr Received | 2016-06-16 |
| Device Manufacturer Date | 2008-02-14 |
| Date Added to Maude | 2016-07-14 |
| 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. YUTAKA YANAGAWA |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SH, 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 | OLYMPUS VISERA PRO XENONLIGHT SOURCE |
| Generic Name | LIGHT SOURCE |
| Product Code | GCT |
| Date Received | 2016-07-14 |
| Returned To Mfg | 2016-06-22 |
| Model Number | CLV-S40PRO |
| 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-SH, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-14 |