MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-02-15 for OLYMPUS OES CYSTONEPHROFIBERSCOPE CYF-5 manufactured by Olympus Medical Systems Corporation.
[20793508]
Olympus was informed that four patients that have had undergone cystoscopy procedures using the referenced device had developed pseudomonas uti, sepsis with the same resistant bacteria and resistance profile. The user facility reported that sterilization process was assessed by an unidentified olympus nurse specialist with no issues observed. The user facility claimed that there was a "nidus" of bacteria within the changed sheath as the device was returned previously for a buckling sheath issue.
Patient Sequence No: 1, Text Type: D, B5
[20901499]
Olympus followed up with the user facility to obtain additional information regarding the report. The user facility reported that the four patients were cultured and the results were positive for the same microorganism. The user facility claimed that the reprocessing area including the basin were cultured with no growth found. The device was sent to an independent testing laboratory for microbiological testing. The results of the testing are pending, and the device has not been returned to olympus for evaluation. This report will be supplemented when the evaluation is complete. As part of our investigation into this report, an olympus endoscopy support specialist was dispatched to the user facility to assess the facility's reprocessing practices and provide reprocessing training if necessary. However, the user facility had declined the in-service. The exact cause of the patients' outcome could not be conclusively determined, but insufficient reprocessing could not be ruled out as a contributory factor. The referenced device was returned to olympus for service/repair on (b)(4) 2012 and a new bending section cover was installed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2013-00064 |
| MDR Report Key | 2974799 |
| Report Source | 06,07 |
| Date Received | 2013-02-15 |
| Date of Report | 2013-01-21 |
| Date Mfgr Received | 2013-01-21 |
| Date Added to Maude | 2013-03-11 |
| 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 | 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 | 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 OES CYSTONEPHROFIBERSCOPE |
| Generic Name | CYSTOSCOPE |
| Product Code | GCQ |
| Date Received | 2013-02-15 |
| Returned To Mfg | 2013-01-25 |
| Model Number | CYF-5 |
| Catalog Number | CYF-5 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-15 |