2026 data FDA MAUDE openFDA FDA Class II

Bronchoscope (Flexible Or Rigid)

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 §874.4680 (Ear, Nose, Throat panel).

FDA MAUDE casebook

openFDA event book Bronchoscope MID-BOOK · MAUDE

#106 of 1000 · 31,113 reports · 1993–2026

  • BOOK 31,113 reports
  • RANK #106 of 1000
  • DEATH 204 death-typed
  • INJ 4,150 injury-typed
  • MALF 26,649 malfunction
  • SPAN 1993–2026
  • PEAK 2025: 6,619
  • PHOTO Wheelchair, Powered

Nearest event-volume peer: Wheelchair, Powered (571 report gap)

Bronchoscope (Flexible Or Rigid) sits #106 of 1000 among tracked device types with 31,113 MAUDE reports spanning 1993–2026. 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

Bronchoscope carries 85.7% MALFUNCTION-coded reports, 20.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.7% corpus 1.5% · below corpus mean (-0.9 pp)
  • INJ 13.3% corpus 30.3% · below corpus mean (-17.0 pp)
  • MALF 85.7% corpus 64.8% · above corpus mean (+20.8 pp)

Lead product-problem code No Display/Image is 25% of coded problems · Lead manufacturer AIZU OLYMPUS CO., LTD. accounts for 72% of manufacturer-tagged reports · Top event location is 88% of location-tagged rows .

Bronchoscope in the event-volume neighbourhood

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

reports

What this shows Bronchoscope (Flexible Or Rigid) carries 31,113 MAUDE reports, ranked #106 of 1000.

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

Event Types

Malfunction 26,649 (85.7%)
Injury 4,150 (13.3%)
Death 204 (0.7%)
Other 96 (0.3%)
14 (0.0%)

Patient Outcomes

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

26,020 (85.1%)
Other 1,593 (5.2%)
Required Intervention 1,178 (3.9%)
R 525 (1.7%)
Hospitalization 517 (1.7%)
H 363 (1.2%)
Death 142 (0.5%)
O 78 (0.3%)
L 69 (0.2%)
Life Threatening 45 (0.1%)
D 27 (0.1%)
Disability 13 (0.0%)
S 2 (0.0%)

Top Product Problems

No Display/Image 7,266
Communication or Transmission Problem 3,325
Peeled/Delaminated 2,733
Adverse Event Without Identified Device or Use Problem 2,621
Break 2,607
Erratic or Intermittent Display 1,511
Poor Quality Image 1,422
Detachment of Device or Device Component 1,328
Thermal Decomposition of Device 1,140
Microbial Contamination of Device 852
Failure to Clean Adequately 777
Fluid/Blood Leak 727
Device Reprocessing Problem 611
Degraded 560
Corroded 559
Display or Visual Feedback Problem 443
Material Split, Cut or Torn 309
Loose or Intermittent Connection 296
Material Deformation 290
Melted 271

Yearly Trend

93
1993: 1
94
1994: 8
95
1995: 1
96
1996: 2
97
1997: 14
98
1998: 9
99
1999: 12
00
2000: 15
01
2001: 14
02
2002: 41
03
2003: 13
04
2004: 23
05
2005: 17
06
2006: 27
07
2007: 39
08
2008: 87
09
2009: 113
10
2010: 100
11
2011: 96
12
2012: 93
13
2013: 93
14
2014: 98
15
2015: 132
16
2016: 297
17
2017: 337
18
2018: 279
19
2019: 654
20
2020: 515
21
2021: 1,358
22
2022: 2,541
23
2023: 5,064
24
2024: 6,051
25
2025: 6,619
26
2026: 6,350

Reports in 2025 (6,619) held close to the prior two-year average of 5,558.

Related Entities for Bronchoscope (Flexible Or Rigid)

Event Locations

27,522 (88.5%)
I 2,709 (8.7%)
HOSPITAL 754 (2.4%)
NO INFORMATION 66 (0.2%)
OTHER 46 (0.1%)
UNKNOWN 7 (0.0%)
HOME 3 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 3 (0.0%)
INVALID DATA 2 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare AIZU OLYMPUS CO., LTD. vs OLYMPUS MEDICAL SYSTEMS CORP. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Bronchoscope: 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 (31,113 here).

Similar death-typed counts

Nearest other device types by death-typed report count (204 here), distinct from the volume row.

Disclaimer: MAUDE figures for Bronchoscope 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 Bronchoscope; 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.