MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-10-03 for OLYMPUS OES CYSTONEPHROFIBERSCOPE CYF-5 manufactured by Olympus Medical Systems Corporation.
[3080303]
Olympus was informed that three male pts developed urinary tract infection (uti) following the use of the referenced device.
Patient Sequence No: 1, Text Type: D, B5
[10282264]
Olympus followed-up with the user facility to obtain additional info regarding this report. The user facility reported that three male pts who had undergone flexible cystoscopy procedure on (b)(6) 2012 had reportedly developed uti with symptoms such as frequency and urgency during urination. Two of the three male pts reportedly went to the er and were provided with antibiotics, and the third pt reportedly was provided with antibiotics by the on-call physician. The user facility reported that the incidences might have been related to their inability to properly clean the referenced device. The user facility reported that the referenced device had never been returned to olympus for service since 2010. An olympus endoscopy support specialist (ess) had conducted an in-service. The ess reported that the user facility was not performing pre-cleaning and leaking testing. Additionally, manual cleaning only consisted of washing the endoscope in detergent and brushing the channel with no flushing performed. High level disinfection consisted of partially submerging the endoscope in cidex. The device referenced in this report was returned to olympus for eval. The eval found slight white residue and debris inside the channel mount unit and at the distal end of the biopsy channel. There was residue or biomaterial buildup on the bending cover. Additionally, peeling was noted on the insertion tube and the bending cover was leaking due to there was a cut at 39mm from the distal tip. The cause of this report appears to be related to user error. This is one of three reports. Please ref 8010047-2012-00369 and 8010047-2012-00370. 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 | 8010047-2012-00371 |
| MDR Report Key | 2818381 |
| Report Source | 06,07 |
| Date Received | 2012-10-03 |
| Date of Report | 2012-09-04 |
| Date of Event | 2012-08-31 |
| Date Mfgr Received | 2012-09-04 |
| Date Added to Maude | 2012-11-15 |
| 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 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS OES CYSTONEPHROFIBERSCOPE |
| Generic Name | CYSTOSCOPE |
| Product Code | GCQ |
| Date Received | 2012-10-03 |
| Returned To Mfg | 2012-09-25 |
| 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 | 1. Other | 2012-10-03 |