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Laryngoscope, Endoscope

Open-data reference.

FDA MAUDE adverse event data · 1993–2026

What the Data Shows About Laryngoscope, Endoscope

The FDA MAUDE database aggregates 1,616 adverse-event reports for Laryngoscope, Endoscope spanning the period from 1993 through 2026. Of these, 3 are classified as death reports, 112 as injury reports, and 1,491 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 8 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 Material Split, Cut or Torn topping the list at 617 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 23 years of MAUDE data, with the peak single-year volume reaching 177 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 5 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.

1,616
Total Reports
3
Death Reports
112
Injury Reports
1,491
Malfunctions

Event Types

Malfunction 1,491 (92.3%)
Injury 112 (6.9%)
Other 8 (0.5%)
Death 3 (0.2%)
2 (0.1%)

Patient Outcomes

1,482 (90.4%)
Required Intervention 62 (3.8%)
Other 59 (3.6%)
R 19 (1.2%)
Hospitalization 10 (0.6%)
H 3 (0.2%)
Death 3 (0.2%)
O 1 (0.1%)

Top Product Problems

Material Split, Cut or Torn 617
Detachment of Device or Device Component 186
Torn Material 151
Break 127
Material Separation 99
Detachment Of Device Component 58
Adverse Event Without Identified Device or Use Problem 20
Difficult to Remove 11
Material Rupture 11
Difficult to Insert 7
Insufficient Information 7
Difficult to Open or Close 6
Device Difficult to Maintain 5
Defective Device 4
Display or Visual Feedback Problem 4
Mechanics Altered 4
Bent 3
Entrapment of Device 3
Material Fragmentation 3
Material Puncture/Hole 3

Yearly Trend

93
1993: 1
96
1996: 1
04
2004: 1
07
2007: 1
08
2008: 2
09
2009: 7
10
2010: 19
11
2011: 49
12
2012: 55
13
2013: 50
14
2014: 106
15
2015: 177
16
2016: 100
17
2017: 130
18
2018: 102
19
2019: 135
20
2020: 129
21
2021: 96
22
2022: 102
23
2023: 101
24
2024: 119
25
2025: 122
26
2026: 11

Related Entities for Laryngoscope, Endoscope

Event Locations

823 (50.9%)
I 724 (44.8%)
HOSPITAL 52 (3.2%)
NO INFORMATION 16 (1.0%)
UNKNOWN 1 (0.1%)

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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.