MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-06-02 for OLYMPUS CYSTOSCOPE CYF-5 manufactured by Olympus Medical Systems Corporation.
[2017553]
The user facility reported that there are two patients that returned to the user facility complaining of chills and fever after having undergone a cystoscopy. Both patients were provided antibiotics. There was no further information provided.
Patient Sequence No: 1, Text Type: D, B5
[8986294]
The device referenced in this report was sent to an independent microbiology laboratory for microbiological testing. Test results from this testing is pending. As part of the investigation into this report, an olympus endoscopy support specialist (ess) was dispatched to visit the user facility to assess the reprocessing practices being employed at the facility. The ess reported that the user facility's staff was using enzol detergent and reusable cleaning brushes during manual cleaning. After cleaning, the staff soaked the insertion tube only in an endo caddy with cidex. Following this cidex soap step, the scope is rinsed, and placed in another endo caddy containing water (which means that the scope was never dried out. ) a physical evaluation of the cystoscope will follow once the cystoscope is received from the laboratory. A supplemental report will be submitted, if additional and significant information becomes available later. The cause of the user's report cannot be conclusively determined, but inadequate reprocessing cannot be ruled out as a causative factor. This report is being submitted as an mdr in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2011-00114 |
| MDR Report Key | 2120465 |
| Report Source | 06 |
| Date Received | 2011-06-02 |
| Date of Report | 2011-05-05 |
| Date of Event | 2011-05-05 |
| Date Mfgr Received | 2011-05-05 |
| 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 | 22-2 NISHI-SHINJUKU SHINJUKU-KU, |
| Manufacturer City | 1-CHOME, TOKYO 163-91 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 163-91 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS CYSTOSCOPE |
| Generic Name | CYSTOSCOPE |
| Product Code | GCQ |
| Date Received | 2011-06-02 |
| Model Number | CYF-5 |
| Lot Number | NA |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | 22-2 NISHI-SHIJUKU SHINJUKU-KU 1-CHOME, TOKYO 163-91 JA 163-91 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-02 |