Hysteroscope (And Accessories)
Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.
OpenFDA device adverse-event casebook.
FDA Class II (moderate risk, special controls required), regulated under 21 CFR §884.1690 (Obstetrics/Gynecology panel).
FDA MAUDE casebook
openFDA event book Hysteroscope LIGHT-BOOK · MAUDE
#241 of 1000 · 8,394 reports · 1992–2026
- BOOK 8,394 reports
- RANK #241 of 1000
- DEATH 41 death-typed
- INJ 1,622 injury-typed
- MALF 6,678 malfunction
- SPAN 1992–2026
- PEAK 2025: 1,719
- PHOTO Abutment
Nearest event-volume peer: Abutment, Implant, Dental, Endosseous (15 report gap)
Hysteroscope (And Accessories) sits #241 of 1000 among tracked device types with 8,394 MAUDE reports spanning 1992–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →
Malfunction reports run above the device-type norm
Hysteroscope carries 79.6% MALFUNCTION-coded reports, 14.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
- INJ 19.3% corpus 30.3% · below corpus mean (-11.0 pp)
- MALF 79.6% corpus 64.8% · above corpus mean (+14.7 pp)
Lead product-problem code Break is 51% of coded problems · Lead manufacturer OLYMPUS WINTER & IBE GMBH accounts for 69% of manufacturer-tagged reports · Top event location is 77% of location-tagged rows .
Hysteroscope in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Guide
Guide, Surgical, Instrument
8,485 reports
- Catheter
Catheter, Peripheral, Atherectomy
8,451 reports
- Dialyzer
Dialyzer, Capillary, Hollow Fiber
8,424 reports
- Acid
Acid, Hyaluronic, Intraarticular
8,410 reports
- Abutment
Abutment, Implant, Dental, Endosseous
8,409 reports
- Hysteroscope (this)
Hysteroscope (And Accessories)
8,394 reports
What this shows Hysteroscope (And Accessories) carries 8,394 MAUDE reports, ranked #241 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2025 (1,719) held close to the prior two-year average of 1,530.
Related Entities for Hysteroscope (And Accessories)
Top Manufacturers
Event Locations
Compare OLYMPUS WINTER & IBE GMBH vs KARL STORZ SE & CO. KG →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Hysteroscope: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (8,394 here).
Similar death-typed counts
Nearest other device types by death-typed report count (41 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Hysteroscope are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.
Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Hysteroscope; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.