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Laryngoscope, Non-Rigid

Open-data reference.

FDA MAUDE adverse event data · 1994–2026

What the Data Shows About Laryngoscope, Non-Rigid

The FDA MAUDE database aggregates 1,074 adverse-event reports for Laryngoscope, Non-Rigid spanning the period from 1994 through 2026. Of these, 6 are classified as death reports, 33 as injury reports, and 1,021 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 7 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 Break topping the list at 433 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 29 years of MAUDE data, with the peak single-year volume reaching 268 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 6 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.

1,074
Total Reports
6
Death Reports
33
Injury Reports
1,021
Malfunctions

Event Types

Malfunction 1,021 (95.1%)
Injury 33 (3.1%)
Other 9 (0.8%)
Death 6 (0.6%)
5 (0.5%)

Patient Outcomes

1,008 (94.1%)
Other 24 (2.2%)
Required Intervention 23 (2.1%)
Hospitalization 7 (0.7%)
Death 6 (0.6%)
Disability 2 (0.2%)
L 1 (0.1%)

Top Product Problems

Break 433
Fluid/Blood Leak 265
Loose or Intermittent Connection 107
Obstruction of Flow 21
Material Fragmentation 7
Poor Quality Image 7
Device Reprocessing Problem 6
Optical Distortion 6
Detachment of Device or Device Component 5
No Display/Image 5
Optical Problem 5
Material Split, Cut or Torn 4
Microbial Contamination of Device 4
Material Separation 3
Metal Shedding Debris 3
Overcorrection 3
Unintended Movement 3
Flaked 2
Material Integrity Problem 2
Nonstandard Device 2

Yearly Trend

94
1994: 1
97
1997: 1
98
1998: 2
99
1999: 5
00
2000: 5
01
2001: 5
02
2002: 8
03
2003: 6
04
2004: 6
06
2006: 2
08
2008: 3
09
2009: 1
10
2010: 49
11
2011: 9
12
2012: 10
13
2013: 21
14
2014: 21
15
2015: 4
16
2016: 7
17
2017: 10
18
2018: 4
19
2019: 1
20
2020: 2
21
2021: 60
22
2022: 258
23
2023: 268
24
2024: 204
25
2025: 87
26
2026: 14

Related Entities for Laryngoscope, Non-Rigid

Event Locations

1,006 (93.7%)
HOSPITAL 30 (2.8%)
I 26 (2.4%)
NO INFORMATION 7 (0.7%)
OTHER 4 (0.4%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.1%)

Compare HOYA CORPORATION PENTAX TOKYO OFFICE vs TELEFLEX MEDICAL →

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.