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

81,401 reports carry this product code, 1992–2026; 15 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.

81,401
reports with this product code: 0.3% of all MAUDE reports; 35,929
reports, 12 months to August 2026: 11,173 in the 12 months before; 98.1%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code FDF is FDA's classification for "Colonoscope and accessories, flexible/rigid" (gastroenterology, Urology panel), a class 2 device. 81,401 medical device reports carry this product code, 0.3% of the MAUDE database, from July 1992 to August 2026.

35,929 reports arrived in the 12 months to August 2026, up 222% from 11,173 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 (98.1%), injury (1.7%) and other (0.1%). 15 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
Pentax	19,083	2,443	0.1%	98.4%
Evis Lucera Elite Colonovideoscope	16,369	9,695	0%	99.4%
Colonovideoscope	9,418	5,712	0%	99.3%
Evis Lucera Colonovideoscope	2,171	1,019	0%	96.8%
Evis Exera Lll Colonovideoscope	1,051	0	0.2%	95.7%
PENTAX Medical	552	807	0.3%	96%
Olympus	415	9	2.5%	69.7%
Evis Lusera Colonovideoscope	411	31	0%	96.1%
Maintenance Unit	374	76	0%	99.8%
Video System Center	348	838	0%	99.8%
Imagina	185	0	0%	100%
CRE Wireguided	136	56	0.3%	93.2%
Ultrasonic Gastrovideoscope	7	902	0.2%	97.6%
Visera Video System Center	2	73	0%	100%
Ultrasonic Probe	1	212	0.5%	91.6%

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	55,513	68.2%
Hoya Pentax Tokyo Office	19,714	24.2%
Olympus Medical Systems	3,870	4.8%
Shirakawa Olympus	783	1%
Olympus Optical	251	0.3%
Olympus Medical System	139	0.2%
Olympus Winter & Ibe	5	0%
Steris	5	0%
Sterilmed	4	0%
Conmed Electrosurgery	2	0%
Aesculap	1	0%
Coopersurgical	1	0%
Olympus Medical Systems Hinode Plant	1	0%
Terumo	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%63

Injury1.7%1,365

Malfunction98.1%79,835

Other0.1%118

Not given0%20

Who filed

Manufacturer report99.4%80,878

Voluntary report0.2%124

User facility report0%0

Distributor report0.3%236

Not given0.2%163

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

Device problems coded

Device problem (FDA code)	Reports	Share
Failure to clean adequately	23,169	28.5%
No display/image	8,438	10.4%
Communication or transmission problemthe device could not communicate or transmit	8,071	9.9%
Device reprocessing problem	5,144	6.3%
Poor quality image	5,054	6.2%
Microbial contamination of device	5,026	6.2%
Breakthe device broke	4,869	6%
Erratic or intermittent display	4,691	5.8%
Optical obstruction	2,616	3.2%
Obstruction of flow	2,502	3.1%
Residue after decontamination	2,473	3%
Fluid/blood leak	2,339	2.9%
Detachment of device or device componentpart of the device came off	1,701	2.1%
Corrodedthe device corroded	1,324	1.6%
Contamination	1,187	1.5%
Optical distortion	766	0.9%
Display or visual feedback problem	542	0.7%
Contamination /decontamination problem	539	0.7%
Image display error/artifact	489	0.6%
Overheating of device	475	0.6%

Questions about colonoscope and accessories, flexible/rigid reports

What is product code FDF?

FDA's classification code for "Colonoscope 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?

81,401 reports through August 2026, 35,929 of them in the latest 12 months.

Which brands appear most often?

Pentax (19,083), Evis Lucera Elite Colonovideoscope (16,369), Colonovideoscope (9,418), Evis Lucera Colonovideoscope (2,171) and Evis Exera Lll Colonovideoscope (1,051). 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.