Urethroscope
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 §876.1500 (Gastroenterology, Urology panel).
FDA MAUDE casebook
openFDA event book Urethroscope LIGHT-BOOK · MAUDE
#530 of 1000 · 1,762 reports · 1995–2026
- BOOK 1,762 reports
- RANK #530 of 1000
- DEATH 0 death-typed
- INJ 7 injury-typed
- MALF 1,755 malfunction
- SPAN 1995–2026
- PEAK 2025: 560
- PHOTO Cannula, Nasal, Oxygen
Nearest event-volume peer: Cannula, Nasal, Oxygen (5 report gap)
Urethroscope sits #530 of 1000 among tracked device types with 1,762 MAUDE reports spanning 1995–2026. 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
Urethroscope carries 99.6% MALFUNCTION-coded reports, 34.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
- INJ 0.4% corpus 30.3% · below corpus mean (-29.9 pp)
- MALF 99.6% corpus 64.8% · above corpus mean (+34.8 pp)
Lead product-problem code Break is 54% of coded problems · Lead manufacturer OLYMPUS WINTER & IBE GMBH accounts for 100% of manufacturer-tagged reports · Top event location is 100% of location-tagged rows .
Urethroscope in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- System
System, Ablation, Microwave And Accessories
1,784 reports
- Cannula
Cannula, Manipulator/Injector, Uterine
1,772 reports
- Cannula
Cannula, Nasal, Oxygen
1,767 reports
- Urethroscope (this)
Urethroscope
1,762 reports
- Agent
Agent, Absorbable Hemostatic, Non-Collagen Based
1,755 reports
- Apparatus
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
1,734 reports
What this shows Urethroscope carries 1,762 MAUDE reports, ranked #530 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 (560) held close to the prior two-year average of 401.
Related Entities for Urethroscope
Top Manufacturers
Event Locations
Compare OLYMPUS WINTER & IBE GMBH vs Olympus Winter & Ibe GmbH →
Nationwide devices with a comparable report-volume footprint
Urethroscope carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (1,762 here).
Similar death-typed counts
Nearest other device types by death-typed report count (0 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Urethroscope 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 Urethroscope; 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.