MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-04-20 for OLYMPUS CYSTOSCOPE CYF-5 manufactured by Olympus Medical Systems Corporation.
[16040903]
The user facility alleged that several patients were reportedly infected with unspecified microorganisms after undergoing a cystoscopy. The patients reportedly experienced the following symptoms approx 24 hours after the procedure: headache, fever, discomfort during urination, and the pts were provided antibiotic.
Patient Sequence No: 1, Text Type: D, B5
[16193257]
The device referenced in this report was sent to an independent microbiology laboratory for microbiological testing. Test results from this testing indicated that the scope cultured positive for (b)(6). 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. However, the user facility informed the ess, that there is no need to review their current reprocessing methods, as the user facility staff do not believe the cystoscope was the source of infections. A physical eval of the cystoscope will follow once the cystoscope is received from the laboratory. A supplemental report will be submitted, if add'l and significant info becomes available later. The cause of the user's report cannot be conclusively determined. This report is being submitted as an mdr in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2011-00082 |
| MDR Report Key | 2075039 |
| Report Source | 06 |
| Date Received | 2011-04-20 |
| Date of Report | 2011-03-26 |
| Date Mfgr Received | 2011-03-26 |
| 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 AVENUE |
| 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, 1-CHOME |
| Manufacturer City | 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 | 2011-04-20 |
| 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-SHINJUKU SHINJUKU-KU, 1-CHOME TOKYO 163-91 JA 163-91 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-20 |