Devices › Cystoscope and accessories, flexible/rigid
Device brand name · Cystonephrofiberscope
Oes Cystonephrofiberscope: medical device reports filed with FDA
1,915 reports name it, 2012–2026. Manufacturer given most often on reports: Shirakawa Olympus. Product code FAJ.
- 1,915
- device reports naming the brand
- 0% of all MAUDE reports · about 139 a year
- 1,093
- reports, 12 months to August 2026
- 195 in the 12 months before
- 93.3%
- classified as malfunction
- 92.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 1,915 reports that name the brand "Oes Cystonephrofiberscope" (cystonephrofiberscope), received between October 2012 and August 2026; the manufacturer given most often on reports is Shirakawa Olympus. Spellings of one product vary from report to report.
1,093 reports arrived in the 12 months to August 2026, up 461% from 195 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (93.3%) and injury (6.7%); across all cystoscope and accessories, flexible/rigid reports (product code FAJ) death is recorded in 0% and malfunction in 92.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are detachment of device or device component (17.9%), microbial contamination of device (12.7%) and failure to clean adequately (12.6%). The patient problems coded most often are urinary tract infection, no patient involvement and bacterial infection. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 11,197 reports carrying product code FAJ. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Detachment of device or device componentpart of the device came off | 343 | 17.9% | 28.3% |
| Microbial contamination of device | 243 | 12.7% | 5.1% |
| Failure to clean adequately | 241 | 12.6% | 8.8% |
| Device reprocessing problem | 185 | 9.7% | 7.2% |
| Breakthe device broke | 153 | 8% | 6.3% |
| Corrodedthe device corroded | 113 | 5.9% | 7.3% |
| Loss of or failure to bond | 75 | 3.9% | 7% |
| Material deformation | 75 | 3.9% | 2.3% |
| Peeled/delaminated | 69 | 3.6% | 2.7% |
| Material separation | 54 | 2.8% | 3.1% |
| Degraded | 48 | 2.5% | 2.2% |
| Material split, cut or torn | 46 | 2.4% | 2.2% |
| Contamination | 40 | 2.1% | 1.4% |
| Poor quality image | 37 | 1.9% | 2% |
| Crackthe device cracked | 35 | 1.8% | 1.9% |
| Environmental particulates | 35 | 1.8% | 0.4% |
| Loose or intermittent connection | 34 | 1.8% | 1.2% |
| Contamination /decontamination problem | 19 | 1% | 1.1% |
| Material fragmentation | 19 | 1% | 1.1% |
| Residue after decontamination | 17 | 0.9% | 0.6% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Urinary tract infectionbladder or urinary infection | 52 | 2.7% |
| No patient involvement | 23 | 1.2% |
| Bacterial infectiona bacterial infection | 16 | 0.8% |
| Dysuriapain on passing urine | 12 | 0.6% |
| Fever | 12 | 0.6% |
| Hematuria | 10 | 0.5% |
| Nauseafeeling sick | 8 | 0.4% |
| Painpain, site not specified | 8 | 0.4% |
| Urinary retentionbeing unable to empty the bladder | 8 | 0.4% |
| Urinary frequency / polyuria | 6 | 0.3% |
| Inflammationinflammation | 5 | 0.3% |
| Sepsisa severe body-wide response to infection | 4 | 0.2% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 3 | 0.2% |
| Interstitial cystitis | 3 | 0.2% |
| Abdominal painstomach or belly pain | 2 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Oes Cystonephrofiberscope | Product code FAJ | All MAUDE reports |
|---|---|---|---|
| Reports | 1,915 | 11,197 | 26,136,888 |
| Share of that pool | — | 17.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 6.7% | 7% | 36.2% |
| Classified as malfunction | 93.3% | 92.6% | 62.3% |
| Filed by the manufacturer | 98.7% | 97.9% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code FAJ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Cysto-Nephro Videoscope | 5,283 | 3,906 | 0% |
| Visera Cysto-Nephro Videoscope | 1,761 | 1,108 | 0% |
| Halogen Light Source | 459 | 55 | 0% |
| Stryker | 559 | 5 | 1.3% |
| Uretero-Reno Fiberscope | 1,778 | 1,053 | 0% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Oes Cystonephrofiberscope reports
How many FDA reports name Oes Cystonephrofiberscope?
1,915 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1,093 in the latest 12 months.
What kinds of events are reported?
malfunction (93.3%) and injury (6.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
detachment of device or device component (17.9%), microbial contamination of device (12.7%), failure to clean adequately (12.6%), device reprocessing problem (9.7%) and break (8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (98.7%) and distributor reports (1.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Oes Cystonephrofiberscope was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.