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Nasopharyngoscope (Flexible Or Rigid)

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FDA MAUDE adverse event data · 2001–2026

What the Data Shows About Nasopharyngoscope (Flexible Or Rigid)

The FDA MAUDE database aggregates 6,163 adverse-event reports for Nasopharyngoscope (Flexible Or Rigid) spanning the period from 2001 through 2026. Of these, 1 is classified as a death report, 101 as injury reports, and 6,056 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 11 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 1,750 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 1,498 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 9 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.

6,163
Total Reports
1
Death Reports
101
Injury Reports
6,056
Malfunctions

Event Types

Malfunction 6,056 (98.3%)
Injury 101 (1.6%)
Other 4 (0.1%)
1 (0.0%)
Death 1 (0.0%)

Patient Outcomes

6,024 (98.0%)
Other 81 (1.3%)
Required Intervention 27 (0.4%)
R 3 (0.0%)
Hospitalization 3 (0.0%)
Life Threatening 3 (0.0%)
O 2 (0.0%)
H 1 (0.0%)
Congenital Anomaly 1 (0.0%)
Death 1 (0.0%)
Disability 1 (0.0%)

Top Product Problems

Break 1,750
Fluid/Blood Leak 1,276
No Display/Image 711
Erratic or Intermittent Display 309
Detachment of Device or Device Component 291
Optical Obstruction 279
Failure to Clean Adequately 249
Device Reprocessing Problem 204
Optical Distortion 126
Peeled/Delaminated 98
Poor Quality Image 87
Material Split, Cut or Torn 71
Unintended Movement 66
Material Separation 57
Corroded 53
Contamination 46
Degraded 43
Crack 38
Optical Problem 35
Component Missing 34

Yearly Trend

01
2001: 4
02
2002: 1
03
2003: 3
04
2004: 1
07
2007: 1
08
2008: 1
09
2009: 3
11
2011: 3
12
2012: 4
13
2013: 5
14
2014: 5
15
2015: 13
16
2016: 16
17
2017: 18
18
2018: 23
19
2019: 51
20
2020: 47
21
2021: 345
22
2022: 1,158
23
2023: 1,352
24
2024: 1,498
25
2025: 1,356
26
2026: 255

Related Entities for Nasopharyngoscope (Flexible Or Rigid)

Event Locations

5,818 (94.4%)
I 285 (4.6%)
HOSPITAL 43 (0.7%)
NO INFORMATION 7 (0.1%)
AMBULATORY SURGICAL FACILITY 4 (0.1%)
OTHER 3 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)
UNKNOWN 1 (0.0%)

Compare HOYA CORPORATION PENTAX TOKYO OFFICE vs SHIRAKAWA OLYMPUS CO., LTD. →

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.