Light source, endoscope, xenon arc: medical device reports filed with FDA

2,381 reports carry this product code, 1996–2026; 10 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.

2,381
reports with this product code: 0% of all MAUDE reports; 558
reports, 12 months to August 2026: 316 in the 12 months before; 94.1%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

Product code GCT is FDA's classification for "Light source, endoscope, xenon arc" (gastroenterology, Urology panel), a class 2 device. 2,381 medical device reports carry this product code, 0% of the MAUDE database, from February 1996 to August 2026.

558 reports arrived in the 12 months to August 2026, up 77% from 316 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 (94.1%), injury (3.7%) and other (1.4%). 10 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
Evis Lucera Elite Xenon Light Source	763	337	0.1%	99.6%
VISERA Pro XENON LIGHT SOURCE	628	70	0%	99.8%
X8000 Lightsource	147	0	0%	99.8%
Visera Xenon Light Source	122	28	0%	98.3%
Visera 4k Uhd Xenon Light Source	87	101	0%	97.9%
X7000 Xenon Lightsource	71	0	0%	92.8%
L9000 Lightsource	68	0	0%	99.2%
Visera Elite Xenon Light Source	12	478	0%	99.6%
Halogen Light Source	6	55	0%	100%
Spacemaker Preperitoneal Dist Balloon	1	0	0%	95.8%

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
Shirakawa Olympus	1,321	55.5%
Stryker Endoscopy San Jose	309	13%
Stryker Endoscopy	35	1.5%
Olympus Medical Systems	27	1.1%
Olympus Optical	9	0.4%
Olympus Medical System	8	0.3%
Stryker	3	0.1%
Ponce - Uss	2	0.1%
Welch Allyn	2	0.1%
Consolidated Medical Equipment	1	0%
Ethicon Endo Surgery	1	0%
Karl Leibinger Medizintechnik & Kg	1	0%
Linvatec	1	0%
Stryker Instruments	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

Death0.2%5

Injury3.7%87

Malfunction94.1%2,241

Other1.4%33

Not given0.6%15

Who filed

Manufacturer report97.8%2,329

Voluntary report0.8%18

User facility report0%0

Distributor report0.3%8

Not given1.1%26

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

Device problems coded

Device problem (FDA code)	Reports	Share
No display/image	453	19%
Poor quality image	240	10.1%
Electrical /electronic property probleman electrical or electronic problem	190	8%
Device displays incorrect message	140	5.9%
Erratic or intermittent display	131	5.5%
Failure to power up	110	4.6%
No device output	110	4.6%
Activation failure	74	3.1%
Output problem	69	2.9%
Breakthe device broke	61	2.6%
Display or visual feedback problem	53	2.2%
Communication or transmission problemthe device could not communicate or transmit	51	2.1%
No visual prompts/feedback	45	1.9%
Loss of powerthe device lost power	42	1.8%
Device operates differently than expectedthe device behaved unexpectedly	41	1.7%
Optical problem	41	1.7%
Defective devicethe device was defective	33	1.4%
Thermal decomposition of device	33	1.4%
Device stops intermittentlythe device stopped now and then	32	1.3%
Overheating of device	30	1.3%

Questions about light source, endoscope, xenon arc reports

What is product code GCT?

FDA's classification code for "Light source, endoscope, xenon arc", 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?

2,381 reports through August 2026, 558 of them in the latest 12 months.

Which brands appear most often?

Evis Lucera Elite Xenon Light Source (763), VISERA Pro XENON LIGHT SOURCE (628), X8000 Lightsource (147), Visera Xenon Light Source (122) and Visera 4k Uhd Xenon Light Source (87). 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.