Device manufacturer, as written on reports

Aomori Olympus: medical device reports filed with FDA

8,423 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.

8,423
reports naming it as manufacturer: 0% of all MAUDE reports; 1,576
reports, 12 months to August 2026: 2,045 in the 12 months before; 71.7%
classified as malfunction: 62.3% across all reports; 0.4%
classified as death, as reported: 0.9% across all reports

8,423 medical device reports received by FDA give Aomori Olympus as the manufacturer of the device involved, 0% of the MAUDE database, from April 2020 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

1,576 reports arrived in the 12 months to August 2026, down 23% from 2,045 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 (71.7%), injury (27.8%) and death (0.4%). 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
THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S	Electrosurgical, cutting & coagulation & accessories	1,599	403	0%
Single Use 3-Lumen Sphincterotome V	Unit, electrosurgical, endoscopic (with or without accessories)	977	256	0.2%
SONICBEAT 5 mm, 35 cm, Front-actuated Grip	Instrument, ultrasonic surgical	820	373	0%
Single Use Electrosurgical Knife	Unit, electrosurgical, endoscopic (with or without accessories)	533	52	0.5%
Single Use Mechanical Lithotriptor V	Lithotriptor, biliary mechanical	379	57	0.5%
Single Use Ligating Device	Ligator, esophageal	364	170	0%
Single Use Aspiration Needle	Bronchoscope accessory	342	144	0.4%
Thunderbeat 5 Mm 20 Cm Front-Actuated Grip Type S	Electrosurgical, cutting & coagulation & accessories	226	45	0%
Balloon	Ultrasound bronchoscope	223	48	0.3%
Single Use Injector	Endoscopic injection needle, gastroenterology-urology	208	40	0%
Single Use Aspiration Needle NA-U401SX	Biopsy needle	176	195	0.2%
Disposable Distal Attachment	Gastroscope and accessories, flexible/rigid	146	24	0%
THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip	Electrosurgical, cutting & coagulation & accessories	126	38	0.3%
Single Use Repositionable Clip	Hemostatic metal clip for the gi tract	101	0	0%
Single Use Electrosurgical Knife KD-650	Unit, electrosurgical, endoscopic (with or without accessories)	100	23	1.7%
Single Use Electrosurgical Hemostatic Forceps	Unit, electrosurgical, endoscopic (with or without accessories)	68	9	0.6%
Disposable Biopsy Forceps	Forceps, biopsy, non-electric	62	8	0%
Sonicbeat 5 Mm 20 Cm Front-Actuated Grip	Instrument, ultrasonic surgical	29	16	0%
THUNDERBEAT Open Extended Jaw	Electrosurgical, cutting & coagulation & accessories	8	12	1%
Thunderbeat Open Fine Jaw	Electrosurgical, cutting & coagulation & accessories	8	1	0%

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
GEI	Electrosurgical, cutting & coagulation & accessories	2,219	26.3%
KNS	Unit, electrosurgical, endoscopic (with or without accessories)	2,112	25.1%
LFL	Instrument, ultrasonic surgical	1,004	11.9%
FCG	Biopsy needle	553	6.6%
LQC	Lithotriptor, biliary mechanical	388	4.6%
PKL	Hemostatic metal clip for the gi tract	307	3.6%
MND	Ligator, esophageal	274	3.3%
FBK	Endoscopic injection needle, gastroenterology-urology	231	2.7%
PSV	Ultrasound bronchoscope	191	2.3%
EOQ	Bronchoscope (flexible or rigid)	123	1.5%

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

Death0.4%37

Injury27.8%2,345

Malfunction71.7%6,041

Other0%0

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 Aomori Olympus reports

How many FDA device reports name Aomori Olympus as manufacturer?

8,423 reports through August 2026, 1,576 of them in the latest 12 months.

Which of its brands appear most often?

THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (1,599), Single Use 3-Lumen Sphincterotome V (977), SONICBEAT 5 mm, 35 cm, Front-actuated Grip (820), Single Use Electrosurgical Knife (533) and Single Use Mechanical Lithotriptor V (379).

Which device types does it report on?

electrosurgical, cutting & coagulation & accessories (26.3%), unit, electrosurgical, endoscopic (with or without accessories) (25.1%), instrument, ultrasonic surgical (11.9%) and biopsy needle (6.6%).

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.