MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-02-06 for VISERA CYSTO-NEPHRO VIDEOSCOPE CYF-VA2 manufactured by Olympus Medical Systems Corp..
[99072329]
The two cyf-va2 were returned to omsc for evaluation. The evaluation found following failures. [cyf-va2, s/n (b)(4), manufactured on september 13, 2015]. - there were kinks in the instrument channel and the insertion tube. - there were debris and scratches inside of the instrument channel. - there were scratches on the rubber of the bending section. - the part of the coating over the insertion tube was peeling off. [cyf-va2, s/n (b)(4), manufactured on november 11, 2010]. - there were kinks in the instrument channel and the insertion tube, the universal cord and the instrument channel. - there were scratches inside of the instrument channel. - there were scratches on the rubber of the bending section and the adhesive of bending rubber. - there was debris on the universal cord. Omsc reviewed the manufacture history of the two cyf-va2 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
[99072330]
Olympus medical systems corp. (omsc) was informed that 8 patients had a fever after a cystoscopy using subject device. The 8 patients reportedly experienced cystoscopy between (b)(6) 2017 and (b)(6) 2018. The facility provided unspecified medical treatment for the patients, but there was no information of the outcome. The facility possesses two cyf-va2 (serial number: (b)(4)), but it is unknown which scope was used for each patient. The user facility conducted microbial culture test for two cyf-va2 and the testing indicated no microbial growth for the two cyf-va2. The user facility reported that the subject device had been reprocessed using endostream, a non-olympus automated endoscope reprocessor model, this report is 2 of 8 reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-00149 |
| MDR Report Key | 7243340 |
| Report Source | USER FACILITY |
| Date Received | 2018-02-06 |
| Date of Report | 2019-02-22 |
| Date of Event | 2017-12-19 |
| Date Mfgr Received | 2019-02-13 |
| Date Added to Maude | 2018-02-06 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | 3 |
| Brand Name | VISERA CYSTO-NEPHRO VIDEOSCOPE |
| Generic Name | CYSTO-NEPHRO VIDEOSCOPE |
| Product Code | NWB |
| Date Received | 2018-02-06 |
| Returned To Mfg | 2018-01-18 |
| Model Number | CYF-VA2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Other | 2018-02-06 |