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Bronchoscope (Flexible Or Rigid)

Open-data reference.

FDA MAUDE adverse event data · 1993–2026

What the Data Shows About Bronchoscope (Flexible Or Rigid)

The FDA MAUDE database aggregates 26,266 adverse-event reports for Bronchoscope (Flexible Or Rigid) spanning the period from 1993 through 2026. Of these, 187 are classified as death reports, 3,763 as injury reports, and 22,206 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 5 distinct event types and 13 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with No Display/Image topping the list at 6,273 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 34 years of MAUDE data, with the peak single-year volume reaching 6,619 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 10 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

26,266
Total Reports
187
Death Reports
3,763
Injury Reports
22,206
Malfunctions

Event Types

Malfunction 22,206 (84.5%)
Injury 3,763 (14.3%)
Death 187 (0.7%)
Other 96 (0.4%)
14 (0.1%)

Patient Outcomes

22,970 (84.9%)
Other 1,532 (5.7%)
Required Intervention 1,022 (3.8%)
R 462 (1.7%)
Hospitalization 456 (1.7%)
H 296 (1.1%)
Death 133 (0.5%)
O 76 (0.3%)
L 53 (0.2%)
Life Threatening 39 (0.1%)
D 19 (0.1%)
Disability 11 (0.0%)
S 2 (0.0%)

Top Product Problems

No Display/Image 6,273
Communication or Transmission Problem 2,863
Peeled/Delaminated 2,482
Break 2,354
Adverse Event Without Identified Device or Use Problem 2,284
Poor Quality Image 1,125
Thermal Decomposition of Device 1,023
Erratic or Intermittent Display 943
Detachment of Device or Device Component 776
Microbial Contamination of Device 737
Fluid/Blood Leak 711
Failure to Clean Adequately 626
Device Reprocessing Problem 465
Degraded 362
Display or Visual Feedback Problem 332
Loose or Intermittent Connection 269
Material Deformation 227
Corroded 218
Optical Obstruction 210
Material Split, Cut or Torn 192

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: 1,503

Related Entities for Bronchoscope (Flexible Or Rigid)

Event Locations

22,718 (86.5%)
I 2,709 (10.3%)
HOSPITAL 711 (2.7%)
NO INFORMATION 66 (0.3%)
OTHER 46 (0.2%)
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. →

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.