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

25,159 reports carry this product code, 1994–2026; 11 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.

25,159
reports with this product code: 0.1% of all MAUDE reports; 9,334
reports, 12 months to August 2026: 2,628 in the 12 months before; 88.5%
classified as malfunction: 62.3% across all reports; 0.7%
classified as death, as reported: 0.9% across all reports

Product code FDT is FDA's classification for "Duodenoscope and accessories, flexible/rigid" (gastroenterology, Urology panel), a class 2 device. 25,159 medical device reports carry this product code, 0.1% of the MAUDE database, from July 1994 to August 2026.

9,334 reports arrived in the 12 months to August 2026, up 255% from 2,628 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 (88.5%), injury (10.5%) and death (0.7%). 11 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 Duodenovideoscope	3,617	1,681	0.8%	89%
Pentax	1,923	2,443	0.1%	98.4%
Evis Lucera Elite Duodenovideoscope	1,370	882	0.2%	88.4%
Single Use Distal Cover	992	102	0%	58%
Evis Exera Duodenovideoscope	930	74	2%	81%
Duodenovideoscope	874	289	0.7%	96.5%
EXALT Model D Single-Use Duodenoscope	306	39	0.7%	79.1%
CRE Wireguided	99	56	0.3%	93.2%
Olympus	18	9	2.5%	69.7%
Single Use Ligating Device	8	170	0%	56.2%
THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip	1	38	0.3%	94.2%

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	15,891	63.2%
Hoya Pentax Tokyo Office	3,825	15.2%
Olympus Medical Systems	3,590	14.3%
Olympus Medical Systems Hinode Plant	858	3.4%
Olympus Medical System	155	0.6%
Olympus Optical	4	0%
Steris	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

Death0.7%187

Injury10.5%2,648

Malfunction88.5%22,259

Other0.1%25

Not given0.2%40

Who filed

Manufacturer report97.6%24,556

Voluntary report0.3%80

User facility report0%0

Distributor report1.8%453

Not given0.3%70

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

Device problems coded

Device problem (FDA code)	Reports	Share
Failure to clean adequately	4,244	16.9%
Crackthe device cracked	2,410	9.6%
Detachment of device or device componentpart of the device came off	2,335	9.3%
Peeled/delaminated	2,318	9.2%
Microbial contamination of device	2,211	8.8%
Loss of or failure to bond	1,768	7%
Device reprocessing problem	1,708	6.8%
Breakthe device broke	1,573	6.3%
Degraded	870	3.5%
Contamination	747	3%
Corrodedthe device corroded	629	2.5%
Residue after decontamination	559	2.2%
Material fragmentation	450	1.8%
Material separation	432	1.7%
Material split, cut or torn	374	1.5%
Device contamination with chemical or other material	347	1.4%
Material discolored	324	1.3%
Mechanical problema mechanical problem	307	1.2%
Contamination /decontamination problem	305	1.2%
Material puncture/hole	287	1.1%

Questions about duodenoscope and accessories, flexible/rigid reports

What is product code FDT?

FDA's classification code for "Duodenoscope 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?

25,159 reports through August 2026, 9,334 of them in the latest 12 months.

Which brands appear most often?

Evis Lucera Duodenovideoscope (3,617), Pentax (1,923), Evis Lucera Elite Duodenovideoscope (1,370), Single Use Distal Cover (992) and Evis Exera Duodenovideoscope (930). 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.