2026 data FDA MAUDE openFDA

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 MAUDE casebook

openFDA event book Urethroscope LIGHT-BOOK · MAUDE

#530 of 1000 · 1,639 reports · 1995–2026

  • BOOK 1,639 reports
  • RANK #530 of 1000
  • DEATH 0 death-typed
  • INJ 7 injury-typed
  • MALF 1,632 malfunction
  • SPAN 1995–2026
  • PEAK 2025: 560
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Ankle, Uncemented, Non-Constrained (2 report gap)

Urethroscope sits #530 of 1000 among tracked device types with 1,639 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 0.4% corpus 30.4% · below corpus mean (-30.0 pp)
  • MALF 99.6% corpus 64.5% · above corpus mean (+35.1 pp)

Lead product-problem code Break is 56% 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

reports

What this shows Urethroscope carries 1,639 MAUDE reports, ranked #530 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 1,632 (99.6%)
Injury 7 (0.4%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

1,584 (99.2%)
R 4 (0.3%)
Other 4 (0.3%)
Hospitalization 3 (0.2%)
L 1 (0.1%)
Required Intervention 1 (0.1%)

Top Product Problems

Break 952
Detachment of Device or Device Component 245
Crack 123
Loose or Intermittent Connection 107
Poor Quality Image 47
Unstable 44
Component Missing 37
Material Twisted/Bent 19
Mechanical Problem 19
Fracture 16
Material Integrity Problem 16
Degraded 13
No Display/Image 11
Optical Problem 11
Material Deformation 10
Material Separation 10
Overheating of Device 9
Defective Component 7
Failure to Align 7
Material Split, Cut or Torn 7

Yearly Trend

95
1995: 1
00
2000: 1
15
2015: 1
17
2017: 1
21
2021: 2
22
2022: 33
23
2023: 346
24
2024: 455
25
2025: 560
26
2026: 239

Related Entities for Urethroscope

Event Locations

1,635 (99.8%)
HOSPITAL 3 (0.2%)
I 1 (0.1%)

Compare OLYMPUS WINTER & IBE GMBH vs OLYMPUS WINTER & IBE GMBH¿ →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Urethroscope, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,639 here).

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

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.