MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-27 for EVIS LUCERA XENON LIGHT SOURCE CLV-260SL manufactured by Olympus Medical Systems Corp..
[131722821]
The subject clv-260sl does not return to olympus. 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
[131722822]
During the unspecified procedure with the clv-260sl, the air feeding of the subject clv-260sl through the unspecified endoscope could not be operated. The user replaced the subject clv-260sl to an unspecified similar system and completed the procedure using the same endoscope. There was no report of the patient? S injury regarding this event. The local service engineer reported the following evaluation result of the subject clv-260sl. The excessive dust collected inside the subject clv-260sl. The air pump incorporated in the subject clv-260sl was faulty. The phenomenon that the user mentioned was reproduced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-02569 |
| MDR Report Key | 8198414 |
| Date Received | 2018-12-27 |
| Date of Report | 2019-01-18 |
| Date of Event | 2018-12-04 |
| Date Mfgr Received | 2018-12-27 |
| Device Manufacturer Date | 2008-06-13 |
| Date Added to Maude | 2018-12-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | EVIS LUCERA XENON LIGHT SOURCE |
| Generic Name | XENON LIGHT SOURCE |
| Product Code | GCT |
| Date Received | 2018-12-27 |
| 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 | 2018-12-27 |