MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-16 for CYSTO-NEPHRO VIDEOSCOPE CYF-VH manufactured by Olympus Medical Systems Corp..
[133511775]
The subject device has not been returned to omsc. Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity. The exact cause could not be determined at present. If significant additional information is received, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[133511776]
Olympus medical systems corp. (omsc) was informed that during routine surveillance culturing tests at the user facility, the subject device tested positive for unspecified bacteria. Other detailed information such as the type and number of the bacteria has not been provided from the user facility at present. There was no report of patient infection associated with the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2019-00864 |
| MDR Report Key | 8251827 |
| Date Received | 2019-01-16 |
| Date of Report | 2019-04-01 |
| Date Mfgr Received | 2019-03-07 |
| Device Manufacturer Date | 2017-12-19 |
| Date Added to Maude | 2019-01-16 |
| 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 | 0 |
| Brand Name | CYSTO-NEPHRO VIDEOSCOPE |
| Generic Name | CYSTO-NEPHRO VIDEOSCOPE |
| Product Code | NWB |
| Date Received | 2019-01-16 |
| Model Number | CYF-VH |
| 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 | 2019-01-16 |