Devices › Light source, fiberoptic, routine
Device brand name · Lightsource
X7000 Xenon Lightsource: medical device reports filed with FDA
321 reports name it, 2005–2012. Manufacturer given most often on reports: Stryker Endoscopy San Jose. Product code FCW.
- 321
- device reports naming the brand
- 0% of all MAUDE reports · about 15 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 92.8%
- 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 321 reports that name the brand "X7000 Xenon Lightsource" (lightsource), received between July 2005 and November 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 (92.8%) and injury (6.5%); 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 loss of power (27.4%), optical problem (17.1%) and application interface becomes non-functional or program exits abnormally (12.1%). The patient problems coded most often are burn, thermal, burn(s) and no patient involvement. 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 X7000 Xenon Lightsource was received in the five years to August 2026; the latest was received in November 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 |
|---|---|---|---|
| Loss of powerthe device lost power | 88 | 27.4% | 6.6% |
| Optical problem | 55 | 17.1% | 4.4% |
| Application interface becomes non-functional or program exits abnormally | 39 | 12.1% | 5.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 37 | 11.5% | 7.2% |
| Overheating of device | 32 | 10% | 9.3% |
| Device stops intermittentlythe device stopped now and then | 23 | 7.2% | 1.8% |
| Device inoperablethe device could not be used | 20 | 6.2% | 1.8% |
| Failure to power up | 16 | 5% | 3.3% |
| Self-activation or keying | 13 | 4% | 1.3% |
| Device displays incorrect message | 10 | 3.1% | 25.7% |
| Temperature problem | 9 | 2.8% | 4.4% |
| No display/image | 7 | 2.2% | 1.7% |
| Mechanical problema mechanical problem | 6 | 1.9% | 1% |
| Breakthe device broke | 5 | 1.6% | 2% |
| Thermal decomposition of device | 3 | 0.9% | 2.7% |
| Device emits odor | 2 | 0.6% | 3.1% |
| Erratic or intermittent display | 2 | 0.6% | 0.2% |
| Fire | 2 | 0.6% | 0.7% |
| Image display error/artifact | 2 | 0.6% | 0.1% |
| No device output | 2 | 0.6% | 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 |
|---|---|---|
| Burn, thermal | 7 | 2.2% |
| Burn(s)a burn | 6 | 1.9% |
| No patient involvement | 3 | 0.9% |
| Therapy/non-surgical treatment, additional | 2 | 0.6% |
| Device induced | 1 | 0.3% |
| Tissue damage | 1 | 0.3% |
| Treatment with medication(s) | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | X7000 Xenon Lightsource | Product code FCW | All MAUDE reports |
|---|---|---|---|
| Reports | 321 | 2,970 | 26,136,888 |
| Share of that pool | — | 10.8% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 6.5% | 5.1% | 36.2% |
| Classified as malfunction | 92.8% | 94.2% | 62.3% |
| Filed by the manufacturer | 99.7% | 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 |
|---|---|---|---|
| X8000 Lightsource | 963 | 0 | 0% |
| Mlx 300w Xenon Lightsource | 558 | 36 | 0% |
| L9000 Lightsource | 385 | 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 X7000 Xenon Lightsource reports
How many FDA reports name X7000 Xenon Lightsource?
321 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 (92.8%) and injury (6.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
loss of power (27.4%), optical problem (17.1%), application interface becomes non-functional or program exits abnormally (12.1%), device operates differently than expected (11.5%) and overheating of device (10%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that X7000 Xenon 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.