Devices › Light source, fiberoptic, routine
Device brand name · Lightsource
X8000 Lightsource: medical device reports filed with FDA
963 reports name it, 2007–2012. Manufacturer given most often on reports: Stryker Endoscopy San Jose. Product code FCW.
- 963
- device reports naming the brand
- 0% of all MAUDE reports · about 50 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 99.8%
- classified as malfunction
- 94.2% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 963 reports that name the brand "X8000 Lightsource" (lightsource), received between June 2007 and August 2012; the manufacturer given most often on reports is Stryker Endoscopy San Jose. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none 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 (99.8%) and injury (0.2%); across all light source, fiberoptic, routine reports (product code FCW) death is recorded in 0% and malfunction in 94.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device displays incorrect message (67.9%), device operates differently than expected (9.1%) and application interface becomes non-functional or program exits abnormally (8.6%). The patient problems coded most often are no patient involvement and burn, thermal. 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
No report naming X8000 Lightsource was received in the five years to August 2026; the latest was received in August 2012.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 2,970 reports carrying product code FCW. 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 |
|---|---|---|---|
| Device displays incorrect message | 654 | 67.9% | 25.7% |
| Device operates differently than expectedthe device behaved unexpectedly | 88 | 9.1% | 7.2% |
| Application interface becomes non-functional or program exits abnormally | 83 | 8.6% | 5.1% |
| Loss of powerthe device lost power | 66 | 6.9% | 6.6% |
| Failure to power up | 30 | 3.1% | 3.3% |
| Optical problem | 27 | 2.8% | 4.4% |
| Device stops intermittentlythe device stopped now and then | 26 | 2.7% | 1.8% |
| Device inoperablethe device could not be used | 17 | 1.8% | 1.8% |
| Self-activation or keying | 17 | 1.8% | 1.3% |
| Breakthe device broke | 10 | 1% | 2% |
| Sticking | 10 | 1% | 0.6% |
| Smoking | 8 | 0.8% | 5.4% |
| Thermal decomposition of device | 6 | 0.6% | 2.7% |
| Mechanical problema mechanical problem | 3 | 0.3% | 1% |
| Overheating of device | 3 | 0.3% | 9.3% |
| Computer operating system problem | 2 | 0.2% | 0.2% |
| Defective component | 2 | 0.2% | 0.1% |
| Difficult to open or close | 2 | 0.2% | 0.1% |
| Mechanical jam | 2 | 0.2% | 0% |
| Melted | 2 | 0.2% | 1.7% |
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 |
|---|---|---|
| No patient involvement | 22 | 2.3% |
| Burn, thermal | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | X8000 Lightsource | Product code FCW | All MAUDE reports |
|---|---|---|---|
| Reports | 963 | 2,970 | 26,136,888 |
| Share of that pool | — | 32.4% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 0.2% | 5.1% | 36.2% |
| Classified as malfunction | 99.8% | 94.2% | 62.3% |
| Filed by the manufacturer | 100% | 96.5% | 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 FCW
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Mlx 300w Xenon Lightsource | 558 | 36 | 0% |
| L9000 Lightsource | 385 | 0 | 0% |
| X7000 Xenon Lightsource | 321 | 0 | 0% |
| All-In-One Ccu+light Row | 256 | 75 | 0% |
| Unknown_Endoscopy_Product | 241 | 22 | 0.4% |
| Mayfield Ultra Base Unit | 495 | 8 | 0% |
| Pentax | 47,288 | 2,443 | 0.1% |
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 X8000 Lightsource reports
How many FDA reports name X8000 Lightsource?
963 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (99.8%) and injury (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device displays incorrect message (67.9%), device operates differently than expected (9.1%), application interface becomes non-functional or program exits abnormally (8.6%), loss of power (6.9%) and failure to power up (3.1%). 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 X8000 Lightsource 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.