MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-11-20 for VISERA CYSTO-NEPHRO VIDEOSCOPE CYF-V2 manufactured by Olympus Medical Systems Corp..
[181477914]
The subject scope was not returned to the service center for evaluation. A review of the service history indicates the scope was purchased on (b)(6) 2013. There was one service event through an advance replacement program on december 24, 2018 for a scope that failed the leak test. The records indicate the user facility received a replacement scope but there is no record that shows the scope that failed the leak test was returned in exchange. As part of the investigation, an endoscopy service specialist (ess) visited the user facility and conducted an observation and an in-service regarding the reprocessing practice. The ess observed the staff was not using a leak tester, a channel brush, and incorrectly performing the high level disinfection process. The ess provided the user facility with reprocessing wall chart guides and trained the staff on how to properly perform pre-cleaning, leak testing, manual cleaning, and manual high level disinfection. The ess informed the user facility of the needed equipment such as leak tester and channel cleaning brush. Additionally, the user facility will plan on purchasing additional equipment in order to take into account the reprocessing time required for the scope to be patient ready. This reported event has been reported by the importer on mdr# 2951238-2019-01190.
Patient Sequence No: 1, Text Type: N, H10
[181477915]
The manufacturer was informed that 24 hours after a cystoscopy procedure, the patient had a fever and needed to be hospitalized. The patient's urine culture indicated that the patient contracted pseudomonas aeruginosa >100,000 cfu/ml. The patient's urine culture on (b)(6) 2019 and prior to the procedure indicated that everything was normal. The facility utilizes aldahol for reprocessing and the aldahol's efficacy is tested daily.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2019-04034 |
| MDR Report Key | 9350372 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-11-20 |
| Date of Report | 2019-11-20 |
| Date of Event | 2019-10-18 |
| Date Mfgr Received | 2019-10-24 |
| Date Added to Maude | 2019-11-20 |
| 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 | VISERA CYSTO-NEPHRO VIDEOSCOPE |
| Generic Name | CYSTO-NEPHRO VIDEOSCOPE |
| Product Code | FAJ |
| Date Received | 2019-11-20 |
| Model Number | CYF-V2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-11-20 |