MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2011-10-27 for OLYMPUS CYSTOSCOPE CYF-5 manufactured by Olympus Medical Systems Corporation.
[2231124]
Olympus was informed that the user facility was not reprocessing the endoscopes in accordance with the directions for use. The user facility personnel were reportedly not performing leakage testing, they were using hand washing detergent instead of enzymatic detergent for manual cleaning, and they do not soak the device in detergent. They were not using a sufficient volume of disinfection cidex plus lcg, and half of the control body unit was not being disinfected. They were not using test strips for the cidex plus and they were not replacing the sterile rinse water between reprocessing cycles and they were only rinsing the device once. No further detailed info was provided.
Patient Sequence No: 1, Text Type: D, B5
[9378190]
No devices were returned to olympus for eval. An olympus endoscopy support specialist (ess) has visited the user facility to review the facility's reprocessing practices, and provided educational materials and inservice training on appropriate reprocessing of endoscopes to user facility personnel. This report is being submitted as a medical device report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2011-00254 |
| MDR Report Key | 2322935 |
| Report Source | 06,07 |
| Date Received | 2011-10-27 |
| Date of Report | 2011-09-28 |
| Date Mfgr Received | 2011-09-28 |
| Date Added to Maude | 2012-05-23 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LAURA STORMS-TYLER |
| Manufacturer Street | 2400 RINGWOOD AVE |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS CYSTOSCOPE |
| Generic Name | CYSTOSCOPE |
| Product Code | GCQ |
| Date Received | 2011-10-27 |
| 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 | 2011-10-27 |