MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-04 for VIDEOSCOPE "CYF-VA2", WITH SUCTION, EUROPEAN VERSION manufactured by Olympus Medical Systems Corp..
[104736904]
The device has not been returned to olympus medical systems corp. (omsc). 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
[104736905]
Olympus was informed that the subject device tested positive for staphylococcus coagulase negative(1 cfu/100 ml)and micrococcaceae(1 cfu/100 ml)during routine surveillance culturing test by the facility. The portion of the subject device, where the microbes were detected, was not reported. The facility had manually reprocessed the subject device with peracetic acid. There was no report of patient infection associated with this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-00573 |
| MDR Report Key | 7394930 |
| Date Received | 2018-04-04 |
| Date of Report | 2019-02-22 |
| Date of Event | 2018-02-16 |
| Date Mfgr Received | 2019-02-13 |
| Date Added to Maude | 2018-04-04 |
| 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 | 0 |
| Brand Name | VIDEOSCOPE "CYF-VA2", WITH SUCTION, EUROPEAN VERSION |
| Generic Name | VISERA CYSTO-NEPHRO VIDEOSCOPE |
| Product Code | NWB |
| Date Received | 2018-04-04 |
| Model Number | CYF-VA2 |
| 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 | 2018-04-04 |