MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-06 for EVIS UNIVERSAL LIGHT SOURCE CLV-U20D manufactured by Olympus Medical Systems Corp..
[92477102]
The subject clv-u20d will be returned to olympus medical systems corp. (omsc) for the evaluation. Omsc continues to investigate this event. Clv-u20d 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
[92477103]
The subject clv-u20d was used for the knee arthroscopic surgery. The subject clv-u20d was turned off after 5 minutes from using the subject clv-u20d. The user replaced the subject clv-u20d with unspecified another device and completed the procedure. The user commented that the user could not hear the sound of the cooling fan in the subject clv-u20d during the procedure. There was no report of the patient? S injury regarding this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2017-01657 |
| MDR Report Key | 7002482 |
| Date Received | 2017-11-06 |
| Date of Report | 2017-12-27 |
| Date of Event | 2017-10-17 |
| Date Mfgr Received | 2017-12-15 |
| Date Added to Maude | 2017-11-06 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 426425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EVIS UNIVERSAL LIGHT SOURCE |
| Product Code | GCT |
| Date Received | 2017-11-06 |
| Returned To Mfg | 2017-10-23 |
| Model Number | CLV-U20D |
| 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 | 2017-11-06 |