MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,user facility report with the FDA on 2010-09-29 for OLYMPUS OES CYSTONEPHROFIBERSCOPE CYF-5 manufactured by Olympus Medical Systems Corporation.
[1433590]
Olympus received a report from the user facility that alleged there were a total of seven patients that had developed urinary (b)(6) infections, and it was not known which of four devices had been alleged to be the source of the infections. The subject device had reportedly been cultured at the user facility, and tested negative. There was no further information provided regarding the status of the patients.
Patient Sequence No: 1, Text Type: D, B5
[8740305]
Olympus followed up with the user facility via phone and in writing to gather more information for this report. The first infection was said to have been identified on (b)(6)2010, but no additional information regarding the status of the patients or the alleged infections was provided. The subject device of this report was forwarded to an independent microbiological testing laboratory for culturing followed by ethylene oxide sterilization. Olympus has been informed that the scope tested negative for growth. Following culturing, the device was forwarded to olympus for evaluation. The instrument channel was examined, and a reddish-orange residue was found inside the device. The evaluation also found that the device failed leak testing at the control body. At the present time, the exact cause of the reported phenomenon cannot be determined, however, insufficient reprocessing and/or user handling cannot be ruled out as contributory factors. The device is awaiting approval from the user facility for service to be performed. If significant additional information is received, a supplemental report will follow. This is report one of four. Please see also mfr#s: 8010047-2010-00184, 8010047-2010-00185 and 8010047-2010-00186. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[39854775]
Oca undertook a retrospective review of its mdr files for the period of january 2005 to april 2015. Based upon this review, we are submitting this supplemental report to separately account for each of the ten patients involved in this event. In addition, this supplemental report is being submitted to provide device evaluation results for the following devices: cyf-5 with serial# (b)(4), cyf-5 with serial# (b)(4), and cyf-5 with serial# (b)(4). Cyf-5 sn# (b)(4): the device was forwarded to a laboratory for microbiological testing. The device tested negative for growth. The device was forwarded to olympus for evaluation following the laboratory microbiological testing. The evaluation found white residue in the instrument channel port and on the distal end of the device. The evaluation also found deep cuts in the insertion tube. Cyf-5 sn# (b)(4): the device was forwarded to a laboratory for microbiological testing. The device tested negative for growth. The device was forwarded to olympus for evaluation following the laboratory microbiological testing. The evaluation found white residue in the instrument channel port and on the distal end of the device. The evaluation also found a leak at the air valve. Cyf-5 sn# (b)(4): the device was forwarded to a laboratory for microbiological testing. The device tested negative for growth. The device was forwarded to olympus for evaluation following the laboratory microbiological testing. The evaluation found white residue in the instrument channel port and on the distal end of the device. The evaluation also found 8 broken image fibers and a leak at the eto valve. Based on the device evaluation results, the most likely cause of the reported events is due to improper maintenance of the device. Please cross reference mfr. Report numbers: 8010047-2010-00184, 8010047-2010-00185, 8010047-2010-00186, 2951238-2016-00155, 2951238-2016-00156, 2951238-2016-00157, 2951238-2016-00158, 2951238-2016-00159, and 2951238-2016-00160 to account for the ten patients as referenced in the original report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2010-00190 |
| MDR Report Key | 1853287 |
| Report Source | 06,USER FACILITY |
| Date Received | 2010-09-29 |
| Date of Report | 2016-03-04 |
| Date of Event | 2016-08-10 |
| Date Mfgr Received | 2010-08-31 |
| Date Added to Maude | 2010-10-07 |
| 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 | 3 |
| Event Location | 3 |
| 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 | CYSTONEPHROFIBERSCOPE |
| Product Code | GCQ |
| Date Received | 2010-09-29 |
| Returned To Mfg | 2010-09-23 |
| Model Number | CYF-5 |
| Lot 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 | 1. Other | 2010-09-29 |