MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-01-07 for OLYMPUS OES CYSTONEPHROFIBERSCOPE CYF-5 manufactured by Olympus Medical Systems Corporation.
[20636075]
Olympus was informed during an in-service that the user facility was omitting all of the pre-cleaning steps, not leak testing all of the time, not using enzymatic cleaning solution, not properly storing the endoscopes, and was not brushing of the scope channel during reprocessing. There were no reports of any pt infections or other adverse impacts to pts as a result of this matter.
Patient Sequence No: 1, Text Type: D, B5
[20867974]
The device reference was not returned to olympus for eval. The users were reportedly high level disinfecting the endoscopes by soaking the endoscopes manually. An olympus endoscope support specialist has provided in-service training to users at this facility and reviewed appropriate reprocessing of this device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2013-00004 |
| MDR Report Key | 2913606 |
| Report Source | 06,07 |
| Date Received | 2013-01-07 |
| Date of Report | 2012-12-10 |
| Date Mfgr Received | 2012-12-10 |
| Date Added to Maude | 2013-02-01 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LAURA STORMS-TYLER |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965688 |
| Manufacturer G1 | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 192-8507 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS OES CYSTONEPHROFIBERSCOPE |
| Generic Name | CYSTOSCOPE |
| Product Code | GCQ |
| Date Received | 2013-01-07 |
| Model Number | CYF-5 |
| Catalog Number | CYF-5 |
| Lot Number | NA |
| ID Number | NA |
| 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 CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-07 |