MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-01-15 for CYSTO-NEPHRO VIDEOSCOPE CYF-VH manufactured by Olympus Medical Systems Corp..
[97868204]
The subject device in this report has not been returned to omsc for evaluation. Omsc reviewed the manufacturing history of this device and confirmed no irregularity. The exact cause of the reported event could not be conclusively determined at this time. If additional information is received, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[97868205]
Olympus medical systems corp. (omsc) was informed that the image of the subject device disappeared during diagnostic procedure. The user facility completed the intended procedure by exchanging the device. There was no patient injury associated with this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-00046 |
| MDR Report Key | 7188812 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-01-15 |
| Date of Report | 2019-02-22 |
| Date of Event | 2017-12-22 |
| Date Mfgr Received | 2019-02-13 |
| Device Manufacturer Date | 2017-05-16 |
| Date Added to Maude | 2018-01-15 |
| 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 | 3 |
| Brand Name | CYSTO-NEPHRO VIDEOSCOPE |
| Generic Name | CYSTO-NEPHRO VIDEOSCOPE |
| Product Code | NWB |
| Date Received | 2018-01-15 |
| Model Number | CYF-VH |
| ID Number | 04953170310461 |
| 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 | 2018-01-15 |