Light source, fiberoptic, routine: medical device reports filed with FDA

2,970 reports carry this product code, 1995–2026; 8 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

2,970
reports with this product code: 0% of all MAUDE reports; 148
reports, 12 months to August 2026: 136 in the 12 months before; 94.2%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code FCW is FDA's classification for "Light source, fiberoptic, routine" (gastroenterology, Urology panel), a class 2 device. 2,970 medical device reports carry this product code, 0% of the MAUDE database, from December 1995 to August 2026.

148 reports arrived in the 12 months to August 2026, close to the 136 of 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 (94.2%), injury (5.1%) and other (0.3%). 8 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
X8000 Lightsource	816	0	0%	99.8%
Mlx 300w Xenon Lightsource	553	36	0%	96.6%
L9000 Lightsource	317	0	0%	99.2%
X7000 Xenon Lightsource	247	0	0%	92.8%
All-In-One Ccu+light Row	117	75	0%	99.2%
Unknown_Endoscopy_Product	11	22	0.4%	69.7%
Mayfield Ultra Base Unit	2	8	0%	94.5%
Pentax	1	2,443	0.1%	98.4%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Stryker Endoscopy San Jose	1,467	49.4%
Integra Lifesciences Ireland	313	10.5%
Stryker Endoscopy-San Jose	296	10%
Medos International S Rl	150	5.1%
Stryker Endoscopy	46	1.5%
Karl Storz Se & Kg	31	1%
Integra Lifesciences	10	0.3%
Integra Lifesciences Oh/USA	7	0.2%
Johnson & Johnson Medical Suzhou	1	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0%1

Injury5.1%150

Malfunction94.2%2,798

Other0.3%9

Not given0.4%12

Who filed

Manufacturer report96.5%2,865

Voluntary report1%29

User facility report0%0

Distributor report1%29

Not given1.6%47

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Device displays incorrect message	762	25.7%
Overheating of device	275	9.3%
Output problem	215	7.2%
Device operates differently than expectedthe device behaved unexpectedly	213	7.2%
Loss of powerthe device lost power	197	6.6%
Smoking	160	5.4%
Application interface becomes non-functional or program exits abnormally	152	5.1%
Display or visual feedback problem	144	4.8%
Optical problem	131	4.4%
Temperature problem	131	4.4%
Failure to power up	97	3.3%
Device emits odor	91	3.1%
Circuit failure	86	2.9%
Thermal decomposition of device	80	2.7%
Breakthe device broke	59	2%
Electrical /electronic property probleman electrical or electronic problem	57	1.9%
Device inoperablethe device could not be used	54	1.8%
Device stops intermittentlythe device stopped now and then	54	1.8%
Melted	51	1.7%
No display/image	51	1.7%

Questions about light source, fiberoptic, routine reports

What is product code FCW?

FDA's classification code for "Light source, fiberoptic, routine", class 2, reviewed by the gastroenterology, Urology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

2,970 reports through August 2026, 148 of them in the latest 12 months.

Which brands appear most often?

X8000 Lightsource (816), Mlx 300w Xenon Lightsource (553), L9000 Lightsource (317), X7000 Xenon Lightsource (247) and All-In-One Ccu+light Row (117). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.