MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-11-19 for CYSTO-NEPHRO VIDEOSCOPE CYF-VHR manufactured by Olympus Medical Systems Corp..
[127594316]
The scope has not returned to olympus for evaluation. The reported complaint cannot be confirmed. Despite several followup attempts, no further information is currently available regarding the infection, the procedure involved, the patient outcome, the specific scope involved, its pre-procedure inspection, or whether the scope device is returning to olympus for evaluation. An olympus endoscopy support specialist has since provided retraining to address the reprocessing issues that were a potential contributing factor. If additional information becomes available, this report will be supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10
[127594317]
1 of 3. During a customer education session on manual cleaning and disinfection, olympus was informed that the user facility had experienced a prior infection incident involving this model scope. The actual scope serial number was not disclosed. The infection type, date of procedure and patient details were not disclosed. It was reported that prior to the education session, the scope reprocessing at the user facility had not been performing the leak test, was not completing pre-cleaning, did not have the appropriate cleaning brushes for the endoscope channels, did not take the irrigation port off between uses, and did not completely immerse the endoscope in high level disinfection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00708 |
| MDR Report Key | 8084684 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-19 |
| Date of Report | 2019-03-01 |
| Date Mfgr Received | 2019-02-13 |
| Date Added to Maude | 2018-11-19 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| 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 | 2018-11-19 |
| Model Number | CYF-VHR |
| Catalog Number | CYF-VHR |
| 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. Other | 2018-11-19 |