PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

Bronchoscope Accessory

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).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Bronchoscope Accessory LIGHT-BOOK · MAUDE

#672 of 1000 · 977 reports · 1994–2026

  • BOOK 977 reports
  • RANK #672 of 1000
  • DEATH 8 death-typed
  • INJ 153 injury-typed
  • MALF 805 malfunction
  • SPAN 1994–2026
  • PEAK 2025: 199
  • PHOTO Container, Sharps

Nearest event-volume peer: Container, Sharps (2 report gap)

Bronchoscope Accessory sits #672 of 1000 among tracked device types with 977 MAUDE reports spanning 1994–2026. 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 Accessory carries 82.4% MALFUNCTION-coded reports, 17.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.8% corpus 1.5% · below corpus mean (-0.7 pp)
  • INJ 15.7% corpus 30.3% · below corpus mean (-14.6 pp)
  • MALF 82.4% corpus 64.8% · above corpus mean (+17.6 pp)

Lead product-problem code Break is 19% of coded problems · Lead manufacturer GYRUS ACMI, INC. accounts for 61% of manufacturer-tagged reports · Top event location is 81% of location-tagged rows .

Bronchoscope Accessory in the event-volume neighbourhood

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

reports

What this shows Bronchoscope Accessory carries 977 MAUDE reports, ranked #672 of 1000.

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

Event Types

Malfunction 805 (82.4%)
Injury 153 (15.7%)
Death 8 (0.8%)
7 (0.7%)
Other 4 (0.4%)

Patient Outcomes

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

771 (80.3%)
Required Intervention 105 (10.9%)
Other 37 (3.9%)
R 15 (1.6%)
Hospitalization 9 (0.9%)
Death 8 (0.8%)
O 5 (0.5%)
H 4 (0.4%)
L 2 (0.2%)
Disability 2 (0.2%)
D 1 (0.1%)
Life Threatening 1 (0.1%)

Top Product Problems

Break 174
Detachment of Device or Device Component 110
Mechanical Problem 68
Material Puncture/Hole 66
Leak/Splash 60
Burst Container or Vessel 56
Material Twisted/Bent 55
Retraction Problem 52
Adverse Event Without Identified Device or Use Problem 38
Material Separation 38
Physical Resistance/Sticking 32
Use of Device Problem 25
Detachment Of Device Component 24
Material Split, Cut or Torn 21
Difficult to Remove 20
Material Perforation 19
Mechanical Jam 19
Fracture 17
Material Fragmentation 16
Deformation Due to Compressive Stress 15

Yearly Trend

94
1994: 2
95
1995: 2
96
1996: 2
98
1998: 1
99
1999: 1
01
2001: 3
02
2002: 6
03
2003: 3
04
2004: 3
05
2005: 1
07
2007: 3
08
2008: 11
09
2009: 9
10
2010: 8
11
2011: 17
12
2012: 12
13
2013: 7
14
2014: 4
15
2015: 2
16
2016: 7
17
2017: 9
18
2018: 14
19
2019: 27
20
2020: 37
21
2021: 47
22
2022: 131
23
2023: 130
24
2024: 149
25
2025: 199
26
2026: 130

Reports rose to 199 in 2025, up from an average of 140 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Bronchoscope Accessory

Top Manufacturers

GYRUS ACMI, INC. 459
BOSTON SCIENTIFIC CORPORATION 139
AOMORI OLYMPUS CO., LTD. 65
GYRUS ACMI, INC 62
BOSTON SCIENTIFIC - CORK 19
GYRUS ACMI INC. 13

Event Locations

794 (81.3%)
I 108 (11.1%)
HOSPITAL 61 (6.2%)
NO INFORMATION 11 (1.1%)
OUTPATIENT DIAGNOSTIC FACILITY 3 (0.3%)

Compare GYRUS ACMI, INC. vs BOSTON SCIENTIFIC CORPORATION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Bronchoscope Accessory: 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 (977 here).

Container, Sharps 979 Digital Breast Tomosynthesis 975 Single-Use Reprocessed Ultrasonic Surgical… 980 Hepatitis A Test 982

Similar death-typed counts

Nearest other device types by death-typed report count (8 here), distinct from the volume row.

Agent 8 Catheter, Balloon, Transcervical 8 Catheter, Nephrostomy 8 Container 8

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Bronchoscope Accessory 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 Accessory; 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.