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 Class II (moderate risk, special controls required), regulated under 21 CFR §874.4720 (Ear, Nose, Throat panel).
FDA MAUDE casebook
openFDA event book Mediastinoscope, Surgical LIGHT-BOOK · MAUDE
#999 of 1000 · 364 reports · 2000–2026
- BOOK 364 reports
- RANK #999 of 1000
- DEATH 0 death-typed
- INJ 23 injury-typed
- MALF 340 malfunction
- SPAN 2000–2026
- PEAK 2025: 105
- PHOTO Temporary Catheter
Nearest event-volume peer: Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures (0 report gap)
Mediastinoscope, Surgical sits #999 of 1000 among tracked device types with 364 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 →
Malfunction reports run above the device-type norm
Mediastinoscope, Surgical carries 93.4% MALFUNCTION-coded reports, 28.6pp 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 6.3% corpus 30.3% · below corpus mean (-24.0 pp)
- MALF 93.4% corpus 64.8% · above corpus mean (+28.6 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 95% of location-tagged rows .
Mediastinoscope, Surgical in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Light
Light, Surgical, Accessories
369 reports
- Material
Material, Impression
369 reports
- Balloon Aorti…
Balloon Aortic Valvuloplasty
367 reports
- Microscope
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
366 reports
- Mediastinosco… (this)
Mediastinoscope, Surgical
364 reports
- Temporary Cat…
Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
364 reports
What this shows Mediastinoscope, Surgical carries 364 MAUDE reports, ranked #999 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 (105) held close to the prior two-year average of 98.
Related Entities for Mediastinoscope, Surgical
Top Manufacturers
Event Locations
Compare OLYMPUS WINTER & IBE GMBH vs KARL STORZ SE & CO. KG →
Nationwide devices with a comparable report-volume footprint
Mediastinoscope, Surgical 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 (364 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 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.