Device manufacturer, as written on reports

Olympus Winter & Ibe: medical device reports filed with FDA

27,809 reports name it as the manufacturer of the device involved, 1996–2026.

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.

27,809
reports naming it as manufacturer: 0.1% of all MAUDE reports; 8,948
reports, 12 months to August 2026: 8,175 in the 12 months before; 95.4%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

27,809 medical device reports received by FDA give Olympus Winter & Ibe as the manufacturer of the device involved, 0.1% of the MAUDE database, from November 1996 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

8,948 reports arrived in the 12 months to August 2026, close to the 8,175 of 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 (95.4%), injury (4.3%) and other (0.2%). 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
Inner sheath, for 26 Fr. outer sheath	Hysteroscope (and accessories)	2,000	533	0%
Video-Optik "ENDOEYE 3D", 30	Endoscope, rigid	1,204	541	0%
Resection sheath, 8 mm, for 8.5 mm/26 Fr. outer sheath, ABS	Hysteroscope (and accessories)	1,056	298	0%
Video telescope "EndoEYE", 10 mm, 30, PAL, HD compatible, autoclavable	Endoscope, accessories, narrow band spectrum	981	355	0%
Telescope "OES ELITE", 4 mm, 30, HD, autoclavable	Urethroscope	870	219	0%
Resection sheath, 24 Fr.	Hysteroscope (and accessories)	758	170	0.1%
HF unit "ESG-400"	Electrosurgical, cutting & coagulation & accessories	509	664	0.1%
Telescope "OES ELITE", 4 mm, 12, HD, autoclavable	Urethroscope	507	112	0%
Telescope 12 4 Mm	Hysteroscope (and accessories)	402	90	0%
Olympus	Colonoscope and accessories, flexible/rigid	356	9	2.5%
Telescope "OES ELITE", 4 mm, 70, HD, autoclavable	Urethroscope	350	187	0%
Telescope 30 4 Mm	Hysteroscope (and accessories)	320	61	0%
Video telescope "ENDOEYE 3D", 10 mm, 0	Endoscope, rigid	293	132	0%
Telescope, 10 mm, 30, HD, quick lock, autoclavable	Mediastinoscope, surgical	248	46	0%
Telescope 70 4 Mm	Hysteroscope (and accessories)	212	66	0%
Telescope 3 Mm 30 Wideangle Autoclavable	Endoscope, ac-powered and accessories	204	42	0%
Electrosurgical Generator Esg-400	Electrosurgical, cutting & coagulation & accessories	169	0	0%
Telescope Ultra 5 4 Mm 30	Laparoscope, general & plastic surgery	168	56	0%
Video telescope "EndoEYE", 10 mm, 0, PAL, HD compatible, autoclavable	Endoscope, accessories, narrow band spectrum	164	64	0%
Oes Cystonephrofiberscope	Cystoscope and accessories, flexible/rigid	69	1,093	0%
HF-resection electrode, loop, 24 Fr., 0.2 wire, medium, 12	Electrode, electrosurgical, active, urological	65	101	0%
Visera Cysto-Nephro Videoscope	Cystoscope and accessories, flexible/rigid	53	1,108	0%
Rhino-Laryngofiberscope	Nasopharyngoscope (flexible or rigid)	43	287	0%
Electrosurgical Generator	Electrosurgical, cutting & coagulation & accessories	4	3	0.6%

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
HET	Laparoscope, gynecologic (and accessories)	12,230	44%
HIH	Hysteroscope (and accessories)	4,718	17%
FGC	Urethroscope	1,762	6.3%
GCM	Endoscope, rigid	1,497	5.4%
NWB	Endoscope, accessories, narrow band spectrum	1,245	4.5%
GCJ	Laparoscope, general & plastic surgery	1,051	3.8%
GEI	Electrosurgical, cutting & coagulation & accessories	955	3.4%
FAS	Electrode, electrosurgical, active, urological	848	3%
GCP	Endoscope, ac-powered and accessories	663	2.4%
HRX	Arthroscope	446	1.6%

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%22

Injury4.3%1,197

Malfunction95.4%26,528

Other0.2%53

Not given0%9

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

Questions about Olympus Winter & Ibe reports

How many FDA device reports name Olympus Winter & Ibe as manufacturer?

27,809 reports through August 2026, 8,948 of them in the latest 12 months.

Which of its brands appear most often?

Inner sheath, for 26 Fr. outer sheath (2,000), Video-Optik "ENDOEYE 3D", 30 (1,204), Resection sheath, 8 mm, for 8.5 mm/26 Fr. outer sheath, ABS (1,056), Video telescope "EndoEYE", 10 mm, 30, PAL, HD compatible, autoclavable (981) and Telescope "OES ELITE", 4 mm, 30, HD, autoclavable (870).

Which device types does it report on?

laparoscope, gynecologic (and accessories) (44%), hysteroscope (and accessories) (17%), urethroscope (6.3%) and endoscope, rigid (5.4%).

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.