MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-02-15 for EVIS LUCERA XENON LIGHT SOURCE CLV-260SL manufactured by Olympus Medical Systems Corp..
[139453711]
The subject clv-260sl was not returned to olympus medical systems corp. (omsc). However, as a result of inspection by an olympus local engineer, no fault was found with the subject clv-260sl. Omsc has continued to investigate the subject clv-260sl to identify the root cause of this failure phenomenon. The clv-260sl 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
[139453712]
During a gastropexy, the endoscopic image on a monitor was flickering when the user connected the unspecified endoscope with the subject clv-260sl. The user replaced the subject clv-260sl with unspecified another device and completed the procedure. There was no report of the patient? S injury regarding this event. However, the user took the subject clv-260sl out of use, because the same flickering endoscopic image issue occurred three times when using the subject clv-260sl in the past.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2019-01088 |
| MDR Report Key | 8342165 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-15 |
| Date of Report | 2019-03-19 |
| Date of Event | 2019-01-31 |
| Date Mfgr Received | 2019-02-18 |
| Device Manufacturer Date | 2013-02-05 |
| Date Added to Maude | 2019-02-15 |
| 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 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 | 3 |
| Brand Name | EVIS LUCERA XENON LIGHT SOURCE |
| Generic Name | XENON LIGHT SOURCE |
| Product Code | GCT |
| Date Received | 2019-02-15 |
| Model Number | CLV-260SL |
| 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 | 2019-02-15 |