MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-01 for EVIS LUCERA XENON LIGHT SOURCE CLV-260 manufactured by Olympus Medical Systems Corp..
[94850673]
The local service staff of olympus checked the following to the subject clv-260 and no abnormality found. Also, this phenomenon was not reproduced. -visual inspection. -image quality. -light output. -internal inspection. -function test. Based on these checking, the local service staff and sales staff surmised as below. -the cable combined with the subject clv-260 was owned by the user. This cable could be faulty. The subject clv-260 was not returned to olympus medical systems corp. (omsc). Omsc checked the device history record of the subject clv-260 and no abnormality found. Omsc could not identify the root cause because the subject clv-260 was not returned to omsc. Based on these informations, omsc surmised this phenomenon might have been occurred by the fault of the cable combined with the subject clv-260. Clv-260 instruction manual states the corresponding method in case of an abnormality. There were no further details provided. If significant additional information is found, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[94850674]
The subject clv-260 which olympus loaned was used for the ebus procedure. The endoscopic image was flicking between color and black/white image when the patient had been sedated and the user set the scope combined with the subject clv-260. The user tried to solve this phenomenon, however this phenomenon was not solved. The user stopped the procedure and re-arranged the procedure. There was no report of the patient? S injury regarding this event. The user reported this phenomenon occurred by the subject clv-260 because the subject clv-260 was the loan.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2017-01893 |
| MDR Report Key | 7073977 |
| Date Received | 2017-12-01 |
| Date of Report | 2017-12-01 |
| Date of Event | 2017-11-13 |
| Date Mfgr Received | 2017-11-13 |
| Date Added to Maude | 2017-12-01 |
| 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 KATSUAKI MORITA |
| 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 | EVIS LUCERA XENON LIGHT SOURCE |
| Generic Name | XENON LIGHT SOURCE |
| Product Code | GCT |
| Date Received | 2017-12-01 |
| Model Number | CLV-260 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-12-01 |