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TPLC
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Device
nasopharyngoscope (flexible or rigid)
Definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product Code
EOB
Regulation Number
874.4760
Device Class
2
Premarket Reviews
Manufacturer
Decision
3NT MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
2
AMBU A/S
SUBSTANTIALLY EQUIVALENT
2
ATMOS MEDIZINTECHNIK GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
1
H&A MUI ENTERPRISES INC.
SUBSTANTIALLY EQUIVALENT
1
HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
KARL STORZ ENDOSCOPY - AMERICA, INC.
SUBSTANTIALLY EQUIVALENT
1
KARL STORZ ENDOSCOPY-AMERICA, INC.
SUBSTANTIALLY EQUIVALENT
1
KARL STORZ SE & CO. KG
SUBSTANTIALLY EQUIVALENT
1
MEDIMAGING INTEGRATED SOLUTION INC. (MIIS)
SUBSTANTIALLY EQUIVALENT
1
OLYMPUS MEDICAL SYSTEMS CORP.
SUBSTANTIALLY EQUIVALENT
4
OPTIM, LLC
SUBSTANTIALLY EQUIVALENT
1
PENTAX OF AMERICA, INC.
SUBSTANTIALLY EQUIVALENT
3
SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
STRYKER
SUBSTANTIALLY EQUIVALENT
1
ZSQUARE, LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
51
51
2020
47
47
2021
346
346
2022
1158
1158
2023
1353
1353
2024
375
375
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
1250
1250
Fluid/Blood Leak
826
826
No Display/Image
228
228
Erratic or Intermittent Display
177
177
Optical Obstruction
128
128
Optical Distortion
116
116
Detachment of Device or Device Component
82
82
Device Reprocessing Problem
66
66
Failure to Clean Adequately
57
57
Unintended Movement
54
54
Peeled/Delaminated
37
37
Poor Quality Image
31
31
Microbial Contamination of Device
25
25
Material Split, Cut or Torn
20
20
Material Separation
19
19
Crack
19
19
Contamination
17
17
Component Missing
16
16
Obstruction of Flow
14
14
Fracture
14
14
Mechanical Problem
13
13
Collapse
11
11
Overcorrection
10
10
Optical Problem
9
9
Adverse Event Without Identified Device or Use Problem
9
9
Degraded
9
9
Misfocusing
7
7
Contamination /Decontamination Problem
7
7
Optical Discoloration
7
7
Scratched Material
7
7
Physical Resistance/Sticking
7
7
Moisture Damage
6
6
Loose or Intermittent Connection
5
5
Display or Visual Feedback Problem
5
5
Use of Device Problem
5
5
Device Fell
5
5
Insufficient Information
5
5
Material Deformation
5
5
Material Integrity Problem
4
4
Improper or Incorrect Procedure or Method
4
4
Fitting Problem
4
4
Defective Device
4
4
Device Contamination with Chemical or Other Material
4
4
Material Fragmentation
4
4
Image Display Error/Artifact
3
3
Delivered as Unsterile Product
3
3
Backflow
3
3
Material Perforation
3
3
Defective Component
3
3
Overheating of Device
3
3
Naturally Worn
3
3
Separation Problem
3
3
Connection Problem
2
2
Device Contaminated During Manufacture or Shipping
2
2
Unsealed Device Packaging
2
2
Unintended System Motion
2
2
Material Rupture
2
2
Signal Artifact/Noise
2
2
Disconnection
2
2
Failure to Disinfect
2
2
Labelling, Instructions for Use or Training Problem
2
2
Material Invagination
2
2
Corroded
2
2
Fogging
1
1
Difficult to Fold, Unfold or Collapse
1
1
Material Frayed
1
1
Material Opacification
1
1
Nonstandard Device
1
1
Display Difficult to Read
1
1
Application Program Problem: Dose Calculation Error
1
1
Flaked
1
1
Complete Blockage
1
1
Coagulation in Device or Device Ingredient
1
1
Loss of or Failure to Bond
1
1
Circuit Failure
1
1
Failure to Advance
1
1
Dent in Material
1
1
Residue After Decontamination
1
1
Dull, Blunt
1
1
Gas/Air Leak
1
1
Flare or Flash
1
1
Sparking
1
1
Blocked Connection
1
1
Communication or Transmission Problem
1
1
Material Puncture/Hole
1
1
Shipping Damage or Problem
1
1
Problem with Sterilization
1
1
Stretched
1
1
Increase in Suction
1
1
Inaccurate Synchronization
1
1
Inadequate or Insufficient Training
1
1
Unraveled Material
1
1
Unstable
1
1
Material Protrusion/Extrusion
1
1
Mechanical Jam
1
1
Moisture or Humidity Problem
1
1
Temperature Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Packaging Problem
1
1
Output Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3185
3185
No Consequences Or Impact To Patient
35
35
No Known Impact Or Consequence To Patient
29
29
Insufficient Information
27
27
No Patient Involvement
17
17
Injury
7
7
Discomfort
5
5
Foreign Body In Patient
5
5
Anaphylactic Shock
4
4
Pain
4
4
Burn(s)
3
3
Blood Loss
3
3
Fever
2
2
Hemorrhage/Bleeding
2
2
Muscle Spasm(s)
2
2
Pneumonia
2
2
Intraoperative Pain
2
2
No Information
2
2
No Code Available
2
2
Unspecified Tissue Injury
1
1
Decreased Appetite
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Device Embedded In Tissue or Plaque
1
1
Patient Problem/Medical Problem
1
1
Low Oxygen Saturation
1
1
Burn, Thermal
1
1
Pneumothorax
1
1
Abrasion
1
1
Paresis
1
1
Perforation
1
1
Pleural Effusion
1
1
Hypersensitivity/Allergic reaction
1
1
Itching Sensation
1
1
Dyspnea
1
1
Edema
1
1
Exposure to Body Fluids
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Karl Storz Endoscopy
II
May-10-2022
2
Olympus Corporation of the Americas
II
Mar-22-2024
3
Olympus Corporation of the Americas
II
Jun-08-2020
4
Shirakawa Olympus Co., Ltd.
II
Jan-09-2024
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