Devices › Cystoscope and accessories, flexible/rigid
Device brand name · Cysto-nephro videoscope
Cysto-Nephro Videoscope: medical device reports filed with FDA
5,283 reports name it, 2015–2026. Manufacturer given most often on reports: Shirakawa Olympus. Product code FAJ.
- 5,283
- device reports naming the brand
- 0% of all MAUDE reports · about 473 a year
- 3,906
- reports, 12 months to August 2026
- 563 in the 12 months before
- 94.9%
- classified as malfunction
- 92.6% across the product code
- 0%
- classified as death, as reported
- 1 reports · not verified by FDA
5,283 medical device reports received by FDA name the brand "Cysto-Nephro Videoscope" (cysto-nephro videoscope); the manufacturer given most often on reports is Shirakawa Olympus; received from May 2015 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
3,906 reports arrived in the 12 months to August 2026, up 594% from 563 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 (94.9%) and injury (5.1%); 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 (44.6%), corroded (10.3%) and loss of or failure to bond (10%). The patient problems coded most often are urinary tract infection, sepsis and fever. 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 | 2,355 | 44.6% | 28.3% |
| Corrodedthe device corroded | 542 | 10.3% | 7.3% |
| Loss of or failure to bond | 530 | 10% | 7% |
| Failure to clean adequately | 489 | 9.3% | 8.8% |
| Device reprocessing problem | 371 | 7% | 7.2% |
| Material separation | 229 | 4.3% | 3.1% |
| Breakthe device broke | 211 | 4% | 6.3% |
| Microbial contamination of device | 170 | 3.2% | 5.1% |
| Peeled/delaminated | 154 | 2.9% | 2.7% |
| Degraded | 135 | 2.6% | 2.2% |
| Crackthe device cracked | 122 | 2.3% | 1.9% |
| Material split, cut or torn | 113 | 2.1% | 2.2% |
| Material deformation | 108 | 2% | 2.3% |
| Contamination | 87 | 1.6% | 1.4% |
| Material fragmentation | 67 | 1.3% | 1.1% |
| Contamination /decontamination problem | 63 | 1.2% | 1.1% |
| Insufficient device problem information | 58 | 1.1% | 0.8% |
| Material discolored | 43 | 0.8% | 0.5% |
| Material integrity problema problem with the device material | 40 | 0.8% | 0.6% |
| Unstable | 33 | 0.6% | 0.4% |
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 | 97 | 1.8% |
| Sepsisa severe body-wide response to infection | 65 | 1.2% |
| Fever | 45 | 0.9% |
| Bacterial infectiona bacterial infection | 22 | 0.4% |
| No patient involvement | 19 | 0.4% |
| Painpain, site not specified | 19 | 0.4% |
| Dysuriapain on passing urine | 15 | 0.3% |
| Urinary frequency / polyuria | 11 | 0.2% |
| Hemorrhage/blood loss/bleeding | 10 | 0.2% |
| Foreign body in patientpart of a device left in the patient | 8 | 0.2% |
| Inflammationinflammation | 8 | 0.2% |
| Hematuria | 7 | 0.1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 6 | 0.1% |
| Chillschills or shivering | 5 | 0.1% |
| Viral infectiona viral infection | 3 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Cysto-Nephro Videoscope | Product code FAJ | All MAUDE reports |
|---|---|---|---|
| Reports | 5,283 | 11,197 | 26,136,888 |
| Share of that pool | — | 47.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 5.1% | 7% | 36.2% |
| Classified as malfunction | 94.9% | 92.6% | 62.3% |
| Filed by the manufacturer | 99.5% | 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 |
|---|---|---|---|
| Oes Cystonephrofiberscope | 1,915 | 1,093 | 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 Cysto-Nephro Videoscope reports
How many FDA reports name Cysto-Nephro Videoscope?
5,283 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 3,906 in the latest 12 months.
What kinds of events are reported?
malfunction (94.9%) and injury (5.1%). "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 (44.6%), corroded (10.3%), loss of or failure to bond (10%), failure to clean adequately (9.3%) and device reprocessing problem (7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.5%) and distributor reports (0.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Cysto-Nephro Videoscope 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.