MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-29 for VISERA ELITE XENON LIGHT SOURCE CLV-S190 manufactured by Olympus Medical Systems Corp..
[125637568]
The subject clv-s190 was not returned to olympus medical systems corp. (omsc) yet. Omsc will investigate the subject clv-s190 to identify the root cause of this failure phenomenon when omsc receives it. The exact cause of the reported event could not be conclusively determined at this time. The clv-s190 instruction manual states the corresponding method when there is an abnormality for the device. 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
[125637589]
The user used the subject xenon light source clv-s190 and video system center otv-s190 in the laparoscopic surgery of gynecology. At the beginning of the procedure, the user inserted the endoscope into the patient? S body. At that time, the color of the endoscopic image became abnormal and the endoscopic image became dark. The user replaced the subject clv-s190 and otv-s190 with the similar device 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 | 8010047-2018-02080 |
| MDR Report Key | 8017559 |
| Date Received | 2018-10-29 |
| Date of Report | 2018-11-19 |
| Date of Event | 2018-10-11 |
| Date Mfgr Received | 2018-10-24 |
| Device Manufacturer Date | 2014-05-27 |
| Date Added to Maude | 2018-10-29 |
| 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 KAZUTAKA MATSUMOTO |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 426425177 |
| 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 | 2018-10-29 |
| Returned To Mfg | 2018-10-19 |
| Model Number | CLV-S190 |
| 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-TO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-29 |