Devices › Endoscope, accessories, narrow band spectrum
Device brand name · Xenon light source
Visera 4k Uhd Xenon Light Source: medical device reports filed with FDA
287 reports name it, 2020–2026. Manufacturer given most often on reports: Shirakawa Olympus. Product code NWB.
- 287
- device reports naming the brand
- 0% of all MAUDE reports · about 46 a year
- 101
- reports, 12 months to August 2026
- 46 in the 12 months before
- 97.9%
- classified as malfunction
- 98.7% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 287 reports that name the brand "Visera 4k Uhd Xenon Light Source" (xenon light source), received between April 2020 and August 2026; the manufacturer given most often on reports is Shirakawa Olympus. Spellings of one product vary from report to report.
101 reports arrived in the 12 months to August 2026, up 120% from 46 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 (97.9%) and injury (2.1%); across all endoscope, accessories, narrow band spectrum reports (product code NWB) death is recorded in 0% and malfunction in 98.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are communication or transmission problem (11.1%), output problem (9.1%) and electrical /electronic property problem (8.4%). The patient problems coded most often are burn(s), partial thickness (second degree) burn and arrhythmia. 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 14,170 reports carrying product code NWB. 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 |
|---|---|---|---|
| Communication or transmission problemthe device could not communicate or transmit | 32 | 11.1% | 25.4% |
| Output problem | 26 | 9.1% | 7.2% |
| Electrical /electronic property probleman electrical or electronic problem | 24 | 8.4% | 8.1% |
| No device output | 20 | 7% | 4.4% |
| Activation failure | 17 | 5.9% | 2.8% |
| Failure to power up | 17 | 5.9% | 4.7% |
| Poor quality image | 14 | 4.9% | 8.3% |
| Breakthe device broke | 12 | 4.2% | 3.7% |
| Connection problema connection problem | 12 | 4.2% | 2.3% |
| Key or button unresponsive/not working | 9 | 3.1% | 1.3% |
| Power problem | 7 | 2.4% | 1.9% |
| Activation problem | 6 | 2.1% | 0.7% |
| Defective component | 6 | 2.1% | 1.3% |
| No visual prompts/feedback | 6 | 2.1% | 2.9% |
| Detachment of device or device componentpart of the device came off | 5 | 1.7% | 0.6% |
| Erratic or intermittent display | 5 | 1.7% | 2.2% |
| Mechanical problema mechanical problem | 5 | 1.7% | 0.8% |
| No display/image | 5 | 1.7% | 10.5% |
| Optical problem | 5 | 1.7% | 1.7% |
| Display or visual feedback problem | 4 | 1.4% | 3.2% |
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 |
|---|---|---|
| Burn(s)a burn | 3 | 1% |
| Partial thickness (second degree) burn | 2 | 0.7% |
| Arrhythmia | 1 | 0.3% |
| Blistera blister | 1 | 0.3% |
| Foreign body in patientpart of a device left in the patient | 1 | 0.3% |
| Hemorrhage/blood loss/bleeding | 1 | 0.3% |
| No patient involvement | 1 | 0.3% |
| Painpain, site not specified | 1 | 0.3% |
| Perforation | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Visera 4k Uhd Xenon Light Source | Product code NWB | All MAUDE reports |
|---|---|---|---|
| Reports | 287 | 14,170 | 26,136,888 |
| Share of that pool | — | 2% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 2.1% | 1.2% | 36.2% |
| Classified as malfunction | 97.9% | 98.7% | 62.3% |
| Filed by the manufacturer | 100% | 99.3% | 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 NWB
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Visera Elite Xenon Light Source | 2,198 | 478 | 0% |
| Video telescope "EndoEYE", 10 mm, 30, PAL, HD compatible, autoclavable | 989 | 355 | 0% |
| Video telescope "EndoEYE", 10 mm, 0, PAL, HD compatible, autoclavable | 164 | 64 | 0% |
| Visera Xenon Light Source | 233 | 28 | 0% |
| Single Use Distal Cover | 1,025 | 102 | 0% |
| Visera Elite Video System Center | 2,688 | 572 | 0% |
| Visera Cysto-Nephro Videoscope | 1,761 | 1,108 | 0% |
| Cysto-Nephro Videoscope | 5,283 | 3,906 | 0% |
| VISERA Pro VIDEO SYSTEM CENTER | 637 | 96 | 0% |
| Halogen Light Source | 459 | 55 | 0% |
| Visera 4k Uhd Camera Control Unit | 1,860 | 425 | 0% |
| Visera Video System Center | 341 | 73 | 0% |
| Video System Center | 3,431 | 838 | 0% |
| VISERA Pro XENON LIGHT SOURCE | 630 | 70 | 0% |
| 4k Autoclavable Camera Head | 3,098 | 723 | 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 Visera 4k Uhd Xenon Light Source reports
How many FDA reports name Visera 4k Uhd Xenon Light Source?
287 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 101 in the latest 12 months.
What kinds of events are reported?
malfunction (97.9%) and injury (2.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
communication or transmission problem (11.1%), output problem (9.1%), electrical /electronic property problem (8.4%), no device output (7%) and activation failure (5.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Visera 4k Uhd Xenon Light Source 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.