MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2017-12-26 for CYSTO-NEPHRO VIDEOSCOPE CYF-VH manufactured by Olympus Medical Systems Corp..
[96019845]
The subject device had not been returned to olympus medical systems corp. (omsc) but was returned to olympus (b)(4). As the evaluation is in progress, the exact cause of the reported event could not be conclusively determined at this time. Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity. If additional information is received, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[96019846]
Olympus was informed that the endoscopic image of the subject device disappeared during an unspecified therapeutic procedure. The facility did not provide detailed information of the event, but there was no report of patient injury associated with this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2017-02090 |
| MDR Report Key | 7145433 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2017-12-26 |
| Date of Report | 2019-02-22 |
| Date Mfgr Received | 2019-02-13 |
| Device Manufacturer Date | 2017-04-03 |
| Date Added to Maude | 2017-12-26 |
| 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 | 3 |
| Brand Name | CYSTO-NEPHRO VIDEOSCOPE |
| Generic Name | CYSTO-NEPHRO VIDEOSCOPE |
| Product Code | NWB |
| Date Received | 2017-12-26 |
| Model Number | CYF-VH |
| ID Number | 04953170310461 |
| 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 | 2017-12-26 |