MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-08-23 for OLYMPUS OES CYSTONEPHROFIBERSCOPE CYF-5- CYF-5 manufactured by Olympus Medical Systems Corp..
[2989610]
Olympus was informed that two of the cystoscopes were found to have rust at the distal end which attributed to pts with excessive pain post-operative. There were no further details provided.
Patient Sequence No: 1, Text Type: D, B5
[10217155]
Olympus followed-up with the user facility to obtain add'l info regarding this report. The user facility reported that 3 pts reportedly had experienced pain after having undergone cystoscopy procedures with the use of their cystoscopes. The user facility reportedly could not determine which endoscope that the pt was complaining about burning during urination immediately following the procedure. The pt reportedly was provided with pyridium and tramadol and was instructed to take ibuprofen. The pt's condition reportedly was improving as reported on (b)(6) 2012. The user facility reportedly identified rust at the distal end of the cystoscopes after receiving complaints from pts relative to burning pain during urination. The device referenced in this report was returned to olympus for eval. The eval found the bending section of the device was stained. The device passed the leakage testing and the insulation testing. As part of the investigation into this report, an olympus endoscopy support specialist was dispatched to the facility to provide in-servicing on appropriate reprocessing. The reported phenomenon was attributed to insufficient cleaning and improper reprocessing. This is one of these reports. Please also reference 8010047-2012-00296 and 00297. 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 | 8010047-2012-00295 |
| MDR Report Key | 2718810 |
| Report Source | 06,07 |
| Date Received | 2012-08-23 |
| Date of Report | 2012-07-26 |
| Date of Event | 2012-07-16 |
| Date Mfgr Received | 2012-07-26 |
| Date Added to Maude | 2012-09-11 |
| 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 | 0 |
| 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 CORP. |
| Manufacturer Street | 2951 ISHIKAWA-CHO HACHIOJI-SHI |
| Manufacturer City | 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 | 2012-08-23 |
| Returned To Mfg | 2012-08-03 |
| 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 CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-23 |