Devices › Hysteroscope (and accessories)
Device brand name · Uterine tissue removal system
Myosure Hysteroscopic Tissue Removal System: medical device reports filed with FDA
215 reports name it, 2011–2019. Manufacturer given most often on reports: Hologic. Product code HIH.
- 215
- device reports naming the brand
- 0% of all MAUDE reports · about 14 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 15.3%
- classified as malfunction
- 79.8% across the product code
- 1.4%
- classified as death, as reported
- 3 reports · not verified by FDA
215 medical device reports received by FDA name the brand "Myosure Hysteroscopic Tissue Removal System" (uterine tissue removal system); the manufacturer given most often on reports is Hologic; received from May 2011 to September 2019. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none 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 injury (83.3%), malfunction (15.3%) and death (1.4%); 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 insufficient device problem information (18.1%), device handling problem (10.2%) and device operates differently than expected (4.2%). The patient problems coded most often are uterine perforation, hypervolemia and perforation. 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
No report naming Myosure Hysteroscopic Tissue Removal System was received in the five years to August 2026; the latest was received in September 2019.
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 |
|---|---|---|---|
| Insufficient device problem information | 39 | 18.1% | 1.9% |
| Device handling problem | 22 | 10.2% | 0.5% |
| Device operates differently than expectedthe device behaved unexpectedly | 9 | 4.2% | 1% |
| Breakthe device broke | 8 | 3.7% | 46.7% |
| Detachment of device component | 8 | 3.7% | 1.1% |
| Metal shedding debris | 6 | 2.8% | 0.3% |
| Improper or incorrect procedure or method | 5 | 2.3% | 0.2% |
| Fluid/blood leak | 3 | 1.4% | 0.2% |
| Therapeutic or diagnostic output failure | 3 | 1.4% | 0.1% |
| Bent | 2 | 0.9% | 0.2% |
| Device, removal of (non-implant) | 2 | 0.9% | 0% |
| Failure to cut | 2 | 0.9% | 0.3% |
| Material fragmentation | 2 | 0.9% | 3.1% |
| Noise, audible | 2 | 0.9% | 0.2% |
| Overfill | 2 | 0.9% | 0% |
| Component falling | 1 | 0.5% | 0.4% |
| Contamination | 1 | 0.5% | 0.2% |
| Decrease in pressure | 1 | 0.5% | 0% |
| Device misassembled during manufacturing /shipping | 1 | 0.5% | 0.1% |
| Device or device fragments location unknown | 1 | 0.5% | 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 |
|---|---|---|
| Uterine perforationa hole in the wall of the womb | 43 | 20% |
| Hypervolemia | 25 | 11.6% |
| Perforation | 25 | 11.6% |
| Hemorrhage/blood loss/bleeding | 23 | 10.7% |
| Blood loss | 7 | 3.3% |
| Bowel perforation | 7 | 3.3% |
| Complaint, ill-defined | 7 | 3.3% |
| Pulmonary edema | 6 | 2.8% |
| Device embedded in tissue or plaque | 5 | 2.3% |
| Internal organ perforation | 5 | 2.3% |
| Painpain, site not specified | 5 | 2.3% |
| Abdominal distention | 4 | 1.9% |
| Abdominal painstomach or belly pain | 4 | 1.9% |
| Breathing difficulties | 4 | 1.9% |
| Foreign body in patientpart of a device left in the patient | 3 | 1.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Myosure Hysteroscopic Tissue Removal System | Product code HIH | All MAUDE reports |
|---|---|---|---|
| Reports | 215 | 8,602 | 26,136,888 |
| Share of that pool | — | 2.5% | 0% |
| Classified as death, per 1,000 reports | 14 | 5 | 9 |
| Classified as injury | 83.3% | 19.1% | 36.2% |
| Classified as malfunction | 15.3% | 79.8% | 62.3% |
| Filed by the manufacturer | 98.6% | 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% |
| TruClear | 481 | 58 | 0.6% |
| Telescope 12 4 Mm | 402 | 90 | 0% |
| Telescope 30 4 Mm | 320 | 61 | 0% |
| Telescope 70 4 Mm | 216 | 66 | 0% |
| 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 Myosure Hysteroscopic Tissue Removal System reports
How many FDA reports name Myosure Hysteroscopic Tissue Removal System?
215 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (83.3%), malfunction (15.3%) and death (1.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (18.1%), device handling problem (10.2%), device operates differently than expected (4.2%), break (3.7%) and detachment of device component (3.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (98.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Myosure Hysteroscopic Tissue Removal System 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.