Hysteroscope (and accessories): medical device reports filed with FDA

8,602 reports carry this product code, 1992–2026; 16 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.

8,602
reports with this product code: 0% of all MAUDE reports; 2,033
reports, 12 months to August 2026: 1,588 in the 12 months before; 79.8%
classified as malfunction: 62.3% across all reports; 0.5%
classified as death, as reported: 0.9% across all reports

Product code HIH is FDA's classification for "Hysteroscope (and accessories)" (obstetrics/Gynecology panel), a class 2 device. 8,602 medical device reports carry this product code, 0% of the MAUDE database, from July 1992 to August 2026.

2,033 reports arrived in the 12 months to August 2026, up 28% from 1,588 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 (79.8%), injury (19.1%) and death (0.5%). 16 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
Inner sheath, for 26 Fr. outer sheath	1,841	533	0%	90.9%
Resection sheath, 8 mm, for 8.5 mm/26 Fr. outer sheath, ABS	1,037	298	0%	98.1%
Resection sheath, 24 Fr.	655	170	0.1%	88.4%
TruClear	473	58	0.6%	78%
Telescope 12 4 Mm	402	90	0%	99.5%
Telescope 30 4 Mm	320	61	0%	99.4%
Telescope 70 4 Mm	216	66	0%	100%
Myosure Hysteroscopic Tissue Removal System	214	0	1.4%	15.3%
Visera Hystero Videoscope	157	157	0%	100%
Oes Hysterofiberscope	150	87	0%	100%
Electrode, bipolar	38	104	0%	53.7%
Fluent Fluid Management System	8	3	0%	95.9%
Novasure	3	140	0.4%	54.8%
High Definition Lcd Monitor	2	565	0%	99.8%
Olympus	1	9	2.5%	69.7%
Stryker	1	5	1.3%	46.3%

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
Olympus Winter & Ibe	4,718	54.8%
Hologic	988	11.5%
Karl Storz Se & Kg	600	7%
Gyrus Acmi	272	3.2%
Shirakawa Olympus	203	2.4%
Smith & Nephew	86	1%
Stryker Endoscopy-San Jose	44	0.5%
Lake Region Medical	13	0.2%
Richard Wolf	9	0.1%
Covidien Mfg Dc Boulder	7	0.1%
Stryker Endoscopy	7	0.1%
Stryker Sustainability Solutions Lakeland	7	0.1%
Caldera Medical	4	0%
Davol	4	0%
Conmed	2	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

Death0.5%41

Injury19.1%1,644

Malfunction79.8%6,864

Other0.5%39

Not given0.2%14

Who filed

Manufacturer report93.2%8,013

Voluntary report1.6%141

User facility report0%0

Distributor report2%172

Not given3.2%276

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

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	4,015	46.7%
Detachment of device or device componentpart of the device came off	1,029	12%
Material fragmentation	266	3.1%
Crackthe device cracked	252	2.9%
Insufficient device problem information	166	1.9%
Loose or intermittent connection	143	1.7%
Material separation	133	1.5%
Mechanical problema mechanical problem	123	1.4%
Fracturea broken bone	116	1.3%
Poor quality image	98	1.1%
Component missing	96	1.1%
Detachment of device component	93	1.1%
Device operates differently than expectedthe device behaved unexpectedly	86	1%
Material integrity problema problem with the device material	85	1%
Material protrusion/extrusion	80	0.9%
Material deformation	79	0.9%
Mechanical jam	66	0.8%
Corrodedthe device corroded	58	0.7%
Failure to clean adequately	56	0.7%
Defective component	54	0.6%

Questions about hysteroscope (and accessories) reports

What is product code HIH?

FDA's classification code for "Hysteroscope (and accessories)", class 2, reviewed by the obstetrics/Gynecology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

8,602 reports through August 2026, 2,033 of them in the latest 12 months.

Which brands appear most often?

Inner sheath, for 26 Fr. outer sheath (1,841), Resection sheath, 8 mm, for 8.5 mm/26 Fr. outer sheath, ABS (1,037), Resection sheath, 24 Fr. (655), TruClear (473) and Telescope 12 4 Mm (402). 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.