Devices › Hysteroscope (and accessories)
Device brand name · Hysteroscope and accessories
TruClear: medical device reports filed with FDA
481 reports name it, 2014–2026. Manufacturer given most often on reports: Covidien Mansfield. Product code HIH.
- 481
- device reports naming the brand
- 0% of all MAUDE reports · about 39 a year
- 58
- reports, 12 months to August 2026
- 71 in the 12 months before
- 78%
- classified as malfunction
- 79.8% across the product code
- 0.6%
- classified as death, as reported
- 3 reports · not verified by FDA
FDA's MAUDE database holds 481 reports that name the brand "TruClear" (hysteroscope and accessories), received between April 2014 and August 2026; the manufacturer given most often on reports is Covidien Mansfield. Spellings of one product vary from report to report.
58 reports arrived in the 12 months to August 2026, down 18% from 71 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 (78%), injury (21.2%) and death (0.6%); across all hysteroscope (and accessories) reports (product code HIH) death is recorded in 0.5% and malfunction in 79.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (26.8%), material protrusion/extrusion (15.6%) and detachment of device or device component (9.8%). The patient problems coded most often are no patient involvement, appropriate clinical signs, symptoms and conditions term/code not available and hemorrhage/blood loss/bleeding. 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."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 8,602 reports carrying product code HIH. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Breakthe device broke | 129 | 26.8% | 46.7% |
| Material protrusion/extrusion | 75 | 15.6% | 0.9% |
| Detachment of device or device componentpart of the device came off | 47 | 9.8% | 12% |
| Material fragmentation | 38 | 7.9% | 3.1% |
| Mechanical jam | 33 | 6.9% | 0.8% |
| Fail-safe problem | 29 | 6% | 0.3% |
| Material deformation | 29 | 6% | 0.9% |
| Material opacification | 29 | 6% | 0.5% |
| Intermittent energy output | 21 | 4.4% | 0.3% |
| Device displays incorrect message | 13 | 2.7% | 0.3% |
| Suction problem | 12 | 2.5% | 0.3% |
| Failure to cut | 11 | 2.3% | 0.3% |
| Detachment of device component | 9 | 1.9% | 1.1% |
| Connection problema connection problem | 8 | 1.7% | 0.1% |
| Energy output problem | 8 | 1.7% | 0.2% |
| Incorrect measurementthe device measured wrongly | 7 | 1.5% | 0.2% |
| Insufficient device problem information | 7 | 1.5% | 1.9% |
| Contamination | 6 | 1.2% | 0.2% |
| Mechanics altered | 6 | 1.2% | 0.2% |
| Self-activation or keying | 6 | 1.2% | 0.1% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| No patient involvement | 66 | 13.7% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 33 | 6.9% |
| Hemorrhage/blood loss/bleeding | 11 | 2.3% |
| Perforation | 10 | 2.1% |
| Uterine perforationa hole in the wall of the womb | 10 | 2.1% |
| Tissue breakdown | 8 | 1.7% |
| Adhesion(s) | 5 | 1% |
| Abdominal painstomach or belly pain | 4 | 0.8% |
| Bowel perforation | 4 | 0.8% |
| Injurya physical injury | 4 | 0.8% |
| Painpain, site not specified | 4 | 0.8% |
| Tissue damage | 4 | 0.8% |
| Blood loss | 3 | 0.6% |
| Fever | 3 | 0.6% |
| Incomplete induced abortion | 3 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | TruClear | Product code HIH | All MAUDE reports |
|---|---|---|---|
| Reports | 481 | 8,602 | 26,136,888 |
| Share of that pool | — | 5.6% | 0% |
| Classified as death, per 1,000 reports | 6 | 5 | 9 |
| Classified as injury | 21.2% | 19.1% | 36.2% |
| Classified as malfunction | 78% | 79.8% | 62.3% |
| Filed by the manufacturer | 96.5% | 93.2% | 94.9% |
Shares are of reports, not 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."
Other brands with product code HIH
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Inner sheath, for 26 Fr. outer sheath | 2,002 | 533 | 0% |
| Resection sheath, 8 mm, for 8.5 mm/26 Fr. outer sheath, ABS | 1,056 | 298 | 0% |
| Resection sheath, 24 Fr. | 759 | 170 | 0.1% |
| Telescope 12 4 Mm | 402 | 90 | 0% |
| Telescope 30 4 Mm | 320 | 61 | 0% |
| Telescope 70 4 Mm | 216 | 66 | 0% |
| Myosure Hysteroscopic Tissue Removal System | 215 | 0 | 1.4% |
| Visera Hystero Videoscope | 157 | 157 | 0% |
| Oes Hysterofiberscope | 150 | 87 | 0% |
| Electrode, bipolar | 203 | 104 | 0% |
| Fluent Fluid Management System | 219 | 3 | 0% |
| Novasure | 1,050 | 140 | 0.4% |
| High Definition Lcd Monitor | 3,553 | 565 | 0% |
| Olympus | 2,240 | 9 | 2.5% |
| Stryker | 559 | 5 | 1.3% |
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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about TruClear reports
How many FDA reports name TruClear?
481 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 58 in the latest 12 months.
What kinds of events are reported?
malfunction (78%), injury (21.2%) and death (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (26.8%), material protrusion/extrusion (15.6%), detachment of device or device component (9.8%), material fragmentation (7.9%) and mechanical jam (6.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (96.5%) and voluntary reports (0.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that TruClear was at fault?
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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.