Bronchoscope (flexible or rigid): medical device reports filed with FDA

32,212 reports carry this product code, 1993–2026; 25 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.

32,212
reports with this product code: 0.1% of all MAUDE reports; 10,363
reports, 12 months to August 2026: 5,857 in the 12 months before; 86%
classified as malfunction: 62.3% across all reports; 0.6%
classified as death, as reported: 0.9% across all reports

Product code EOQ is FDA's classification for "Bronchoscope (flexible or rigid)" (ear, Nose, Throat panel), a class 2 device. 32,212 medical device reports carry this product code, 0.1% of the MAUDE database, from December 1993 to August 2026.

10,363 reports arrived in the 12 months to August 2026, up 77% from 5,857 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 (86%), injury (13%) and death (0.6%). 25 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 Bronchovideoscope	5,881	2,352	0%	98.6%
Bronchovideoscope	1,921	938	0.1%	98.6%
Ion	1,748	499	8.2%	14%
Evis Lucera Bronchovideoscope	1,596	407	0.1%	91.9%
Tracheal Intubation Fiberscope	1,169	324	0%	98.8%
Oes Bronchofiberscope	487	112	0%	92.2%
Airway Mobilescope	429	182	0%	98.6%
Evis Lucera Bronchofibervideoscope	351	71	0%	95.2%
Bronchofiberscope	322	126	0.3%	93.8%
SINGLE USE BIOPSY VALVE (Sterile)	284	130	0%	51.2%
Single Use Suction Valve Sterile	279	0	0%	98.2%
Evis Exeraii Bronchovideoscope	252	0	0.8%	38.5%
Evis Exera Bronchovideoscope	244	34	4.5%	66%
Visera Tracheal Intubation Videoscope	157	67	0%	98.7%
Halogen Light Source	154	55	0%	100%
Olympus	135	9	2.5%	69.7%
Pentax	127	2,443	0.1%	98.4%
Disposable Biopsy Forceps	64	8	0%	45.3%
Single Use Aspiration Needle	29	144	0.4%	79.4%
Balloon	3	48	0.3%	71.5%
Evis X1 Video System Center	3	858	0%	98.1%
PENTAX Medical	2	807	0.3%	96%
Superdimension Inreach Bronchus System	2	0	14.1%	15%
Karl Storz	1	0	2.1%	24.6%
Superdimension	1	5	7%	12.3%

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	21,639	67.2%
Olympus Medical Systems	3,116	9.7%
Hoya Pentax Tokyo Office	2,704	8.4%
Intuitive Surgical	1,797	5.6%
Olympus Medical Systems Hinode Plant	303	0.9%
Olympus Medical System	200	0.6%
Verathon Medical Ulc	150	0.5%
Aomori Olympus	123	0.4%
Olympus Optical	118	0.4%
Boston Scientific - Spencer	90	0.3%
Covidien - Superdimension	45	0.1%
Gyrus Acmi	32	0.1%
Conmed	19	0.1%
Boston Scientific - Costa Rica	17	0.1%
Boston Scientific - Costa Rica Heredia	6	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

Death0.6%207

Injury13%4,203

Malfunction86%27,692

Other0.3%96

Not given0%14

Who filed

Manufacturer report97.8%31,496

Voluntary report0.5%151

User facility report0%0

Distributor report1%335

Not given0.7%230

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

Device problems coded

Device problem (FDA code)	Reports	Share
No display/image	7,452	23.1%
Communication or transmission problemthe device could not communicate or transmit	3,437	10.7%
Peeled/delaminated	2,794	8.7%
Breakthe device broke	2,650	8.2%
Erratic or intermittent display	1,631	5.1%
Detachment of device or device componentpart of the device came off	1,493	4.6%
Poor quality image	1,462	4.5%
Thermal decomposition of device	1,177	3.7%
Microbial contamination of device	850	2.6%
Failure to clean adequately	804	2.5%
Fluid/blood leak	732	2.3%
Corrodedthe device corroded	649	2%
Device reprocessing problem	640	2%
Degraded	622	1.9%
Display or visual feedback problem	472	1.5%
Material split, cut or torn	326	1%
Material deformation	310	1%
Material fragmentation	304	0.9%
Loose or intermittent connection	297	0.9%
Melted	280	0.9%

Questions about bronchoscope (flexible or rigid) reports

What is product code EOQ?

FDA's classification code for "Bronchoscope (flexible or rigid)", class 2, reviewed by the ear, Nose, Throat panel. Every device report carries the product code of the device involved.

How many reports carry this code?

32,212 reports through August 2026, 10,363 of them in the latest 12 months.

Which brands appear most often?

Evis Lucera Elite Bronchovideoscope (5,881), Bronchovideoscope (1,921), Ion (1,748), Evis Lucera Bronchovideoscope (1,596) and Tracheal Intubation Fiberscope (1,169). 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.