MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-15 for EVIS LUCERA ELITE XENON LIGHT SOURCE CLV-290SL manufactured by Olympus Medical Systems Corp..
[106023293]
The subject clv-290sl has not been returned to olympus medical systems corp. (omsc) yet. Omsc will investigate the subject clv-290sl to determine the cause of this phenomenon when omsc receives it. Clv-290sl instruction manual states the corresponding method in case of an abnormality. 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
[106023294]
During the emr procedure using the clv-290sl and cv-290, pcf-h290i, the user attempted to remove the suction tube from the pcf-h290i in order to attach a suction trap. At that time, as the scope connector part of the pcf-h290i was pushed, all areas in the image displayed on the monitor screen got dark to black and did not return to normal. The user moved with the patient to another operating room and completed the procedure using an unspecified similar system. After the procedure was completed, the same phenomenon was reproduced as the image lost on the monitor by applying the lateral stress to the scope connector of the pcf-h290i. There was no report of the patient? S injury regarding this event other than moving the patient to another operating room or replacing of device.
Patient Sequence No: 1, Text Type: D, B5
[117903475]
This is a supplemental report for mfr report #8010047 - 2018? 00649. The subject clv-290sl was returned to olympus medical systems corp. (omsc). Functional checks were performed with the subject clv-290sl (sn (b)(4)) which was connected to cv-290 (sn (b)(4)) and pcf-h290i(sn (b)(4) those were used when the reported malfunction occurred, and oev262h (omsc asset). As a result, the reported malfunction was not reproduced. Except for the reported phenomenon, "e216" scope communication error occurred. The investigation of the subject clv-290sl confirmed the following details: no abnormality was found in the subject clv-290sl when it was operated in the system stated above. The system including the subject cv-290 was turned on and off repeatedly. The pcf-h290i was applied lateral stress to the scope connector. Power was continuously supplied to the system including the subject clv-290sl. The system including the subject cv-290 was turned on and off repeatedly. The pcf-h290i was applied lateral stress to the scope connector. The log data of the cv-290 was confirmed. ("e216" scope communication error occurred. ) omsc performed an investigation on the actual clv-290sl. The reported phenomenon was not reproduced. The root cause of this phenomenon could not be conclusively determined. There is a possibility that temporary communication failure between the subject cv-290 and the pcf-h290i occurred, resulting malfunction of the endoscope image.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2018-00650 |
| MDR Report Key | 7431893 |
| Date Received | 2018-04-15 |
| Date of Report | 2018-05-23 |
| Date of Event | 2018-03-19 |
| Date Mfgr Received | 2018-05-14 |
| Date Added to Maude | 2018-04-15 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 426425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EVIS LUCERA ELITE XENON LIGHT SOURCE |
| Generic Name | XENON LIGHT SOURCE |
| Product Code | GCT |
| Date Received | 2018-04-15 |
| Model Number | CLV-290SL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-04-15 |