Devices › Hysteroscope (and accessories)
Device brand name · A22040a
Inner sheath, for 26 Fr. outer sheath: medical device reports filed with FDA
2,002 reports name it, 2012–2026. Manufacturer given most often on reports: Olympus Winter & Ibe. Product code HIH.
- 2,002
- device reports naming the brand
- 0% of all MAUDE reports · about 145 a year
- 533
- reports, 12 months to August 2026
- 466 in the 12 months before
- 90.9%
- classified as malfunction
- 79.8% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 2,002 reports that name the brand "Inner sheath, for 26 Fr. outer sheath" (A22040a), received between September 2012 and August 2026; the manufacturer given most often on reports is Olympus Winter & Ibe. Spellings of one product vary from report to report.
533 reports arrived in the 12 months to August 2026, up 14% from 466 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 (90.9%), injury (9%) and other (0.1%); 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 (73%), detachment of device or device component (13.9%) and material fragmentation (6.9%). The patient problems coded most often are foreign body in patient, device embedded in tissue or plaque 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 | 1,461 | 73% | 46.7% |
| Detachment of device or device componentpart of the device came off | 278 | 13.9% | 12% |
| Material fragmentation | 138 | 6.9% | 3.1% |
| Fracturea broken bone | 131 | 6.5% | 1.3% |
| Mechanical problema mechanical problem | 112 | 5.6% | 1.4% |
| Crackthe device cracked | 100 | 5% | 2.9% |
| Loose or intermittent connection | 33 | 1.6% | 1.7% |
| Component missing | 24 | 1.2% | 1.1% |
| Material integrity problema problem with the device material | 24 | 1.2% | 1% |
| Scratched material | 20 | 1% | 0.5% |
| Unstable | 16 | 0.8% | 0.5% |
| Material deformation | 13 | 0.6% | 0.9% |
| Material separation | 13 | 0.6% | 1.5% |
| Detachment of device component | 10 | 0.5% | 1.1% |
| Loss of or failure to bond | 10 | 0.5% | 0.6% |
| Defective component | 9 | 0.4% | 0.6% |
| Degraded | 8 | 0.4% | 0.4% |
| Component falling | 7 | 0.3% | 0.4% |
| Material twisted/bent | 6 | 0.3% | 0.4% |
| Dent in material | 5 | 0.2% | 0.3% |
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 |
|---|---|---|
| Foreign body in patientpart of a device left in the patient | 53 | 2.6% |
| Device embedded in tissue or plaque | 16 | 0.8% |
| Hemorrhage/blood loss/bleeding | 4 | 0.2% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 3 | 0.1% |
| Tissue irritation | 2 | 0.1% |
| Blood loss | 1 | 0% |
| Complaint, ill-defined | 1 | 0% |
| Discomfortdiscomfort | 1 | 0% |
| Dysuriapain on passing urine | 1 | 0% |
| Fever | 1 | 0% |
| Injurya physical injury | 1 | 0% |
| Laceration(s) | 1 | 0% |
| Painpain, site not specified | 1 | 0% |
| Skin tears | 1 | 0% |
| Thrombus | 1 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Inner sheath, for 26 Fr. outer sheath | Product code HIH | All MAUDE reports |
|---|---|---|---|
| Reports | 2,002 | 8,602 | 26,136,888 |
| Share of that pool | — | 23.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 5 | 9 |
| Classified as injury | 9% | 19.1% | 36.2% |
| Classified as malfunction | 90.9% | 79.8% | 62.3% |
| Filed by the manufacturer | 97.7% | 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 |
|---|---|---|---|
| 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% |
| 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 Inner sheath, for 26 Fr. outer sheath reports
How many FDA reports name Inner sheath, for 26 Fr. outer sheath?
2,002 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 533 in the latest 12 months.
What kinds of events are reported?
malfunction (90.9%), injury (9%) and other (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (73%), detachment of device or device component (13.9%), material fragmentation (6.9%), fracture (6.5%) and mechanical problem (5.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (97.7%), distributor reports (2.1%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Inner sheath, for 26 Fr. outer sheath 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.