MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-06-25 for CYSTO-NEPHRO VIDEOSCOPE CYF-VHA manufactured by Olympus Medical Systems Corp..
[112140659]
The subject device was returned to olympus for evaluation. The evaluation confirmed foreign materials within the instrument channel port and a deformation in the instrument channel of the subject device. Omsc reviewed the manufacture history of the subject device and confirmed no irregularity the exact cause could not be determined at present, but the insufficient reprocessing by the user facility cannot be ruled out as the cause of this event.
Patient Sequence No: 1, Text Type: N, H10
[112140660]
Olympus medical systems corp. (omsc) was informed that three of six patients, who undergone unspecified cystoscopy with the subject device, suffered mild prostatitis since they purchased the subject device on (b)(6) 2018. It was reported that the three patients were treated with antibiotic and in good condition after the procedure. The facility reported that they had used another cystoscope before (b)(6) and there was no prostatitis. Omsc followed up with the facility to obtain additional information. The facility reported that they manually reprocessed the subject device using glutaraldehyde and the subject device passed the leakage test during reprocessing. In addition following deviations from the instructions of the subject device were reported from the facility. -the facility did not use medical detergent solution but a detergent solution for household. -they did not attached adapter to the channels of the subject device during the reprocessing and they flush the channels directly using running water. This is one of three repots.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-01208 |
| MDR Report Key | 7633183 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-06-25 |
| Date of Report | 2019-02-26 |
| Date Mfgr Received | 2019-02-13 |
| Device Manufacturer Date | 2018-01-18 |
| Date Added to Maude | 2018-06-25 |
| 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 | 3 |
| Brand Name | CYSTO-NEPHRO VIDEOSCOPE |
| Generic Name | CYSTO-NEPHRO VIDEOSCOPE |
| Product Code | NWB |
| Date Received | 2018-06-25 |
| Returned To Mfg | 2018-06-07 |
| Model Number | CYF-VHA |
| 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 | 2018-06-25 |