2026 data FDA MAUDE openFDA

Mediastinoscope, Surgical

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 Mediastinoscope, Surgical LIGHT-BOOK · MAUDE

#988 of 1000 · 355 reports · 2000–2026

  • BOOK 355 reports
  • RANK #988 of 1000
  • DEATH 0 death-typed
  • INJ 23 injury-typed
  • MALF 331 malfunction
  • SPAN 2000–2026
  • PEAK 2025: 105
  • PHOTO Analyzer

Nearest event-volume peer: Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use (1 report gap)

Mediastinoscope, Surgical sits #988 of 1000 among tracked device types with 355 MAUDE reports spanning 2000–2026. 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 6.5% corpus 30.4% · below corpus mean (-24.0 pp)
  • MALF 93.2% corpus 64.5% · above corpus mean (+28.7 pp)

Lead product-problem code Break is 47% of coded problems · Lead manufacturer OLYMPUS WINTER & IBE GMBH accounts for 95% of manufacturer-tagged reports · Top event location is 94% of location-tagged rows .

Mediastinoscope, Surgical in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Mediastinoscope, Surgical carries 355 MAUDE reports, ranked #988 of 1000.

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

Event Types

Malfunction 331 (93.2%)
Injury 23 (6.5%)
Other 1 (0.3%)

Patient Outcomes

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

322 (91.7%)
Other 18 (5.1%)
Required Intervention 6 (1.7%)
Hospitalization 3 (0.9%)
R 1 (0.3%)
Disability 1 (0.3%)

Top Product Problems

Break 168
Detachment of Device or Device Component 70
Crack 18
Component Missing 15
Loose or Intermittent Connection 15
Adverse Event Without Identified Device or Use Problem 13
Poor Quality Image 8
Material Integrity Problem 7
Material Separation 7
Mechanical Problem 6
Sharp Edges 6
Naturally Worn 4
Material Deformation 3
Optical Problem 3
Scratched Material 3
Defective Component 2
Degraded 2
Device Operates Differently Than Expected 2
Material Split, Cut or Torn 2
Output Problem 2

Yearly Trend

00
2000: 2
06
2006: 2
10
2010: 1
11
2011: 1
15
2015: 2
16
2016: 12
17
2017: 2
21
2021: 4
22
2022: 9
23
2023: 97
24
2024: 99
25
2025: 105
26
2026: 19

Related Entities for Mediastinoscope, Surgical

Event Locations

335 (94.4%)
I 13 (3.7%)
HOSPITAL 4 (1.1%)
NO INFORMATION 2 (0.6%)
AMBULATORY SURGICAL FACILITY 1 (0.3%)

Compare OLYMPUS WINTER & IBE GMBH vs KARL STORZ SE & CO. KG →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Mediastinoscope, Surgical, 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 (355 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 Mediastinoscope, Surgical 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 Mediastinoscope, Surgical; 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.