MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature,user facil report with the FDA on 2016-04-20 for OLYMPUS VISERA ELITE XENON LIGHT SOURCE CLV-S190 manufactured by Olympus Medical Systems Corp..
[43167428]
The subjected device was returned to olympus medical systems corp. (omsc) for evaluation. Omsc evaluated the device and found that the phenomenon was reproduced. Furthermore omsc found that the power-supply unit did not output the lighting voltage for the xenon lamp. Omsc evaluated the power-supply unit and found that the resistance mounted to the circuit board had the marks of heat and the resistance was broken. Omsc replaced this resistance with another one. The power-supply unit outputted the lighting voltage for the xenon lamp appropriately. So omsc surmised that the breakage of this resistance was the cause of this phenomenon. Omsc surmised that the cause of the breakage of the resistance is the following in theory. Any foreign material (e. G. Dust, smother) was attached to a high-voltage generating circuit of the unit that is supplied a voltage from this power-supply unit. An electric charge leaked through any foreign material. The power-supply unit supplied a large voltage unintentionally. As a result, an electrical load in the circuit of the power-supply unit had intensified. The resistance developed fever and the resistance was broken. The (b)(4) instruction manual states the corresponding method when the xenon lamp went out and the cleaning procedure for the device. There were no further details provided. If significant additional information is received, this report will be supplemented. This report is being submitted as a medical device report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[43167429]
Olympus was informed that the xenon lamp went out and the emergency lamp lighted up during an unspecified ent procedure. As a result of investigation, olympus was informed the following information on march 25th 2016. At this case, the facility replaced the (b)(4) with a spare device made by (b)(4), 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 | 8010047-2016-00494 |
| MDR Report Key | 5589791 |
| Report Source | FOREIGN,LITERATURE,USER FACIL |
| Date Received | 2016-04-20 |
| Date of Report | 2016-04-20 |
| Date of Event | 2015-11-25 |
| Date Mfgr Received | 2016-03-25 |
| Device Manufacturer Date | 2015-02-09 |
| Date Added to Maude | 2016-04-20 |
| 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-SHI, TOKYO 1928507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 1928507 |
| Manufacturer Phone | 42 6425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS VISERA ELITE XENON LIGHT SOURCE |
| Generic Name | LIGHT SOURCE |
| Product Code | GCT |
| Date Received | 2016-04-20 |
| Returned To Mfg | 2016-03-07 |
| Catalog 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. Required No Informationntervention | 2016-04-20 |