Device manufacturer, as written on reports

Aizu Olympus: medical device reports filed with FDA

169,133 reports name it as the manufacturer of the device involved, 2020–2026.

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.

169,133
reports naming it as manufacturer: 0.7% of all MAUDE reports; 97,228
reports, 12 months to August 2026: 27,029 in the 12 months before; 98.3%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

169,133 medical device reports received by FDA give Aizu Olympus as the manufacturer of the device involved, 0.7% of the MAUDE database, from January 2020 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

97,228 reports arrived in the 12 months to August 2026, up 260% from 27,029 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 (98.3%), injury (1.6%) and death (0.1%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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 named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Evis Lucera Elite Gastrointestinal Videoscope	Gastroscope and accessories, flexible/rigid	17,404	11,247	0%
Evis Lucera Elite Colonovideoscope	Colonoscope and accessories, flexible/rigid	15,804	9,695	0%
Gastrointestinal Videoscope	Gastroscope and accessories, flexible/rigid	13,401	8,589	0%
Colonovideoscope	Colonoscope and accessories, flexible/rigid	9,254	5,712	0%
Endoeye Flex Deflectable Videoscope	Laparoscope, general & plastic surgery	6,278	2,245	0%
Evis Lucera Elite Bronchovideoscope	Bronchoscope (flexible or rigid)	5,708	2,352	0%
Evis Lucera Gastrointestinal Videoscope	Gastroscope and accessories, flexible/rigid	5,604	2,491	0.2%
Evis Lucera Duodenovideoscope	Duodenoscope and accessories, flexible/rigid	2,899	1,681	0.8%
Uretero-Reno Videoscope	Ureteroscope and accessories, flexible/rigid	2,263	1,862	0%
Evis Lucera Colonovideoscope	Colonoscope and accessories, flexible/rigid	1,959	1,019	0%
Bronchovideoscope	Bronchoscope (flexible or rigid)	1,835	938	0.1%
Endoeye Flex 3d Deflectable Videoscope	Laparoscope, general & plastic surgery	1,577	711	0%
Endoscope Reprocessor	Accessories, cleaning, for endoscope	1,324	276	0%
Evis Lucera Elite Duodenovideoscope	Duodenoscope and accessories, flexible/rigid	1,299	882	0.2%
Uretero-Reno Fiberscope	Ureteroscope and accessories, flexible/rigid	1,250	1,053	0%
EVIS EXERA lll GASTROINTESTINAL VIDEOSCOPE	Gastroscope and accessories, flexible/rigid	1,233	674	0%
Evis Lucera Bronchovideoscope	Bronchoscope (flexible or rigid)	1,204	407	0.1%
Tracheal Intubation Fiberscope	Bronchoscope (flexible or rigid)	927	324	0%
Connecting Tube	Accessories, cleaning, for endoscope	755	19	0%
Duodenovideoscope	Duodenoscope and accessories, flexible/rigid	676	289	0.7%
Evis Exera Duodenovideoscope	Duodenoscope and accessories, flexible/rigid	375	74	2%
Evis Lusera Colonovideoscope	Colonoscope and accessories, flexible/rigid	355	31	0%
Olympus Endoscope Reprocessor	Accessories, cleaning, for endoscope	294	41	0%
Airway Mobilescope	Bronchoscope (flexible or rigid)	145	182	0%
Bronchofiberscope	Bronchoscope (flexible or rigid)	104	126	0.3%
Forceps/Irrigation Plug Isolated Type	Ureteroscope and accessories, flexible/rigid	103	2	0.8%
Choledocho Videoscope	Choledochoscope and accessories, flexible/rigid	89	108	0.6%
Oes Bronchofiberscope	Bronchoscope (flexible or rigid)	81	112	0%
Evis Exera Gastrointestinal Videoscope	Gastroscope and accessories, flexible/rigid	46	64	0%
Evis Exera Lll Colonovideoscope	Colonoscope and accessories, flexible/rigid	3	0	0.2%

Brands with a page on this site, 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."

Device types

Product code	Device type	Reports	Share
FDS	Gastroscope and accessories, flexible/rigid	60,030	35.5%
FDF	Colonoscope and accessories, flexible/rigid	55,513	32.8%
EOQ	Bronchoscope (flexible or rigid)	21,639	12.8%
FDT	Duodenoscope and accessories, flexible/rigid	15,891	9.4%
GCJ	Laparoscope, general & plastic surgery	8,224	4.9%
FGB	Ureteroscope and accessories, flexible/rigid	3,930	2.3%
FEB	Accessories, cleaning, for endoscope	2,705	1.6%
FDA	Enteroscope and accessories	420	0.2%
FAJ	Cystoscope and accessories, flexible/rigid	240	0.1%
FBN	Choledochoscope and accessories, flexible/rigid	183	0.1%

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

Death0.1%95

Injury1.6%2,742

Malfunction98.3%166,294

Other0%2

Not given0%0

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Aizu Olympus reports

How many FDA device reports name Aizu Olympus as manufacturer?

169,133 reports through August 2026, 97,228 of them in the latest 12 months.

Which of its brands appear most often?

Evis Lucera Elite Gastrointestinal Videoscope (17,404), Evis Lucera Elite Colonovideoscope (15,804), Gastrointestinal Videoscope (13,401), Colonovideoscope (9,254) and Endoeye Flex Deflectable Videoscope (6,278).

Which device types does it report on?

gastroscope and accessories, flexible/rigid (35.5%), colonoscope and accessories, flexible/rigid (32.8%), bronchoscope (flexible or rigid) (12.8%) and duodenoscope and accessories, flexible/rigid (9.4%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. 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."

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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.