MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,foreign,user facility report with the FDA on 2012-10-03 for OES CYSTONEPHROFIBERSCOPE CYF-5 manufactured by Olympus Medical Systems Corporation.
[3082085]
Olympus was informed that four patients got prostatitis after having undergone a cystoscopy. There was no information provided regarding what, if any, treatment had been provided to the patients.
Patient Sequence No: 1, Text Type: D, B5
[10233190]
Olympus sales representative visited the user facility and reviewed the user facility's reprocessing method, and noted that the users didn't completely put the device in disinfection solution, brushes weren't exchanged regularly, and were worn out. The subject device was not returned to olympus for evaluation. The evaluation found slight residue in the instrument channel port and the distal end. At the present time, the exact cause of the reported phenomenon cannot be determined, however insufficient reprocessing and user handling cannot be ruled out as contributory factors. If significant additional information is received, a supplemental report will follow. This report is being submitted as a medical device report in an abundance of caution. Cross reference mfr report# 8010047-2012-00344, 8010047-2012-00345, 8010047-2012-00346.
Patient Sequence No: 1, Text Type: N, H10
[36601107]
Olympus medical systems corporation (omsc) performed an mdr retrospective review and omsc found that this supplemental report is required on december 24, 2015. This supplemental report is being submitted to provide the review result for the manufacture history of the subject device, put check mark in "other serious", correct "other" to "serious injury", and delete incorrect description stating that "the evaluation found slight residue in the instrument channel port and the distal end". Omsc reviewed the manufacture history of the subject device, there was no irregularity found. Please cross-reference mfr. Report# 8010047-2012-00344,8010047-2012-00345,8010047-2012-00346.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2012-00343 |
| MDR Report Key | 2796849 |
| Report Source | 01,06,FOREIGN,USER FACILITY |
| Date Received | 2012-10-03 |
| Date of Report | 2016-01-21 |
| Date Mfgr Received | 2012-09-13 |
| Date Added to Maude | 2012-10-25 |
| 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 | SUSUMU NISHINA |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OES CYSTONEPHROFIBERSCOPE |
| Generic Name | CYSTOSCOPE |
| Product Code | GCQ |
| Date Received | 2012-10-03 |
| Model Number | CYF-5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 |