MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-09-14 for VIDEOSCOPE "CYF-V2", EUROPEAN VERSION manufactured by Olympus Medical Systems Corp..
[120527727]
The subject device has not been returned to omsc. 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
[120527728]
Olympus medical systems corp. (omsc) was informed that the subject device tested positive for unspecified bacteria (2cfu/100ml) during a routine surveillance culturing test at the facility. It was reported that the user facility had manually reprocessed the subject device with peracetic acid. There was no report of patient infection associated with the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-01775 |
| MDR Report Key | 7875752 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-09-14 |
| Date of Report | 2019-02-22 |
| Date of Event | 2018-08-08 |
| Date Mfgr Received | 2019-02-13 |
| Device Manufacturer Date | 2014-01-28 |
| Date Added to Maude | 2018-09-14 |
| 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 | VIDEOSCOPE "CYF-V2", EUROPEAN VERSION |
| Generic Name | CYSTO-NEPHRO VIDEOSCOPE |
| Product Code | NWB |
| Date Received | 2018-09-14 |
| Model Number | CYF-V2 |
| 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 | 2018-09-14 |