Gastroscope and accessories, flexible/rigid: medical device reports filed with FDA

76,761 reports carry this product code, 1992–2026; 19 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.

76,761
reports with this product code: 0.3% of all MAUDE reports; 38,652
reports, 12 months to August 2026: 10,812 in the 12 months before; 98.4%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code FDS is FDA's classification for "Gastroscope and accessories, flexible/rigid" (gastroenterology, Urology panel), a class 2 device. 76,761 medical device reports carry this product code, 0.3% of the MAUDE database, from January 1992 to August 2026.

38,652 reports arrived in the 12 months to August 2026, up 257% from 10,812 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 (98.4%), injury (1.4%) and other (0.1%). 19 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 Gastrointestinal Videoscope	17,900	11,247	0%	99.4%
Gastrointestinal Videoscope	13,633	8,589	0%	99.7%
Pentax	12,329	2,443	0.1%	98.4%
Evis Lucera Gastrointestinal Videoscope	6,041	2,491	0.2%	96.6%
EVIS EXERA lll GASTROINTESTINAL VIDEOSCOPE	1,282	674	0%	99.4%
Evis Exera Gastrointestinal Videoscope	353	64	0%	96.9%
PENTAX Medical	247	807	0.3%	96%
Disposable Distal Attachment	184	24	0%	29.9%
Imagina	78	0	0%	100%
Halogen Light Source	53	55	0%	100%
Olympus	24	9	2.5%	69.7%
Balloon	21	48	0.3%	71.5%
Video System	19	73	0%	100%
SINGLE USE BIOPSY VALVE (Sterile)	6	130	0%	51.2%
Ultrasonic Gastrovideoscope	4	902	0.2%	97.6%
Colonovideoscope	1	5,712	0%	99.3%
Evis Exera Lll Colonovideoscope	1	0	0.2%	95.7%
Evis Lucera Duodenovideoscope	1	1,681	0.8%	89%
Single Use Ligating Device	1	170	0%	56.2%

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
Aizu Olympus	60,030	78.2%
Hoya Pentax Tokyo Office	12,629	16.5%
Olympus Medical Systems	3,240	4.2%
Aomori Olympus	122	0.2%
Olympus Optical	78	0.1%
Olympus Medical System	40	0.1%
Olympus Medical Systems Hinode Plant	7	0%
Guidant Cardiac Surgery	4	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%54

Injury1.4%1,107

Malfunction98.4%75,533

Other0.1%59

Not given0%8

Who filed

Manufacturer report99.7%76,509

Voluntary report0.1%46

User facility report0%0

Distributor report0.2%156

Not given0.1%50

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

Device problems coded

Device problem (FDA code)	Reports	Share
Failure to clean adequately	22,647	29.5%
Poor quality image	8,585	11.2%
Communication or transmission problemthe device could not communicate or transmit	6,124	8%
No display/image	5,985	7.8%
Device reprocessing problem	5,871	7.6%
Erratic or intermittent display	4,395	5.7%
Residue after decontamination	4,262	5.6%
Microbial contamination of device	3,072	4%
Breakthe device broke	2,665	3.5%
Fluid/blood leak	2,093	2.7%
Obstruction of flow	2,050	2.7%
Corrodedthe device corroded	1,744	2.3%
Contamination	1,135	1.5%
Detachment of device or device componentpart of the device came off	1,134	1.5%
Thermal decomposition of device	1,099	1.4%
Optical obstruction	1,081	1.4%
Melted	939	1.2%
Image display error/artifact	871	1.1%
Overheating of device	682	0.9%
Contamination /decontamination problem	670	0.9%

Questions about gastroscope and accessories, flexible/rigid reports

What is product code FDS?

FDA's classification code for "Gastroscope and accessories, flexible/rigid", 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?

76,761 reports through August 2026, 38,652 of them in the latest 12 months.

Which brands appear most often?

Evis Lucera Elite Gastrointestinal Videoscope (17,900), Gastrointestinal Videoscope (13,633), Pentax (12,329), Evis Lucera Gastrointestinal Videoscope (6,041) and EVIS EXERA lll GASTROINTESTINAL VIDEOSCOPE (1,282). 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.