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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
3
HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
KARL STORZ ENDOSCOPY - AMERICA, INC.
SUBSTANTIALLY EQUIVALENT
1
KARL STORZ ENDOSCOPY-AMERICA, INC.
SUBSTANTIALLY EQUIVALENT
2
KARL STORZ SE & CO. KG
SUBSTANTIALLY EQUIVALENT
1
MEDIMAGING INTEGRATED SOLUTION INC. (MIIS)
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC XOMED INC.
SUBSTANTIALLY EQUIVALENT
1
OLYMPUS MEDICAL SYSTEMS CORP.
SUBSTANTIALLY EQUIVALENT
5
OPTIM, LLC
SUBSTANTIALLY EQUIVALENT
1
PENTAX MEDICAL
SUBSTANTIALLY EQUIVALENT
2
PENTAX OF AMERICA, INC.
SUBSTANTIALLY EQUIVALENT
3
STRYKER
SUBSTANTIALLY EQUIVALENT
1
ZSQUARE, LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
23
23
2019
51
51
2020
47
47
2021
346
346
2022
1158
1158
2023
432
432
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
938
938
Fluid/Blood Leak
486
486
Optical Distortion
103
103
No Display/Image
66
66
Unintended Movement
48
48
Device Reprocessing Problem
37
37
Detachment of Device or Device Component
35
35
Optical Obstruction
33
33
Poor Quality Image
29
29
Peeled/Delaminated
17
17
Component Missing
16
16
Crack
16
16
Contamination
15
15
Microbial Contamination of Device
15
15
Erratic or Intermittent Display
14
14
Fracture
13
13
Failure to Clean Adequately
13
13
Material Separation
12
12
Obstruction of Flow
11
11
Collapse
11
11
Scratched Material
11
11
Mechanical Problem
10
10
Degraded
9
9
Loose or Intermittent Connection
8
8
Adverse Event Without Identified Device or Use Problem
8
8
Material Split, Cut or Torn
8
8
Physical Resistance/Sticking
7
7
Overcorrection
7
7
Optical Problem
6
6
Misfocusing
6
6
Moisture Damage
6
6
Contamination /Decontamination Problem
6
6
Device Contamination with Chemical or Other Material
5
5
Material Deformation
5
5
Use of Device Problem
5
5
Device Fell
5
5
Insufficient Information
4
4
Fitting Problem
4
4
Image Display Error/Artifact
4
4
Display or Visual Feedback Problem
4
4
Material Fragmentation
3
3
Delivered as Unsterile Product
3
3
Backflow
3
3
Material Perforation
3
3
Defective Component
3
3
Improper or Incorrect Procedure or Method
3
3
Defective Device
3
3
Optical Discoloration
3
3
Naturally Worn
3
3
Device Contaminated During Manufacture or Shipping
2
2
Output Problem
2
2
Unsealed Device Packaging
2
2
Unintended System Motion
2
2
Signal Artifact/Noise
2
2
Corroded
2
2
Failure to Disinfect
2
2
Labelling, Instructions for Use or Training Problem
2
2
Material Invagination
2
2
Material Frayed
1
1
Application Program Problem: Dose Calculation Error
1
1
Fogging
1
1
Difficult to Fold, Unfold or Collapse
1
1
Material Opacification
1
1
Nonstandard Device
1
1
Display Difficult to Read
1
1
Material Discolored
1
1
Disconnection
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
Overheating of Device
1
1
Material Rupture
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
Device Inoperable
1
1
Unraveled Material
1
1
Residue After Decontamination
1
1
Communication or Transmission Problem
1
1
Connection Problem
1
1
Material Integrity Problem
1
1
Material Protrusion/Extrusion
1
1
Mechanical Jam
1
1
Gas/Air Leak
1
1
Electrical Shorting
1
1
Flare or Flash
1
1
Appropriate Term/Code Not Available
1
1
Device Handling Problem
1
1
Activation Failure
1
1
Noise, Audible
1
1
Patient Device Interaction Problem
1
1
Packaging Problem
1
1
Temperature Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Unexpected Shutdown
1
1
Excessive Heating
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1903
1903
No Known Impact Or Consequence To Patient
48
48
No Consequences Or Impact To Patient
36
36
Insufficient Information
23
23
No Patient Involvement
18
18
Injury
7
7
Pain
4
4
Anaphylactic Shock
4
4
Foreign Body In Patient
3
3
No Information
3
3
Blood Loss
3
3
No Code Available
2
2
Intraoperative Pain
2
2
Fever
2
2
Hemorrhage/Bleeding
2
2
Muscle Spasm(s)
2
2
Abrasion
1
1
Burn, Thermal
1
1
Paresis
1
1
Perforation
1
1
Pleural Effusion
1
1
Pneumonia
1
1
Pneumothorax
1
1
Hypersensitivity/Allergic reaction
1
1
Itching Sensation
1
1
Exposure to Body Fluids
1
1
Burn(s)
1
1
Dyspnea
1
1
Edema
1
1
Patient Problem/Medical Problem
1
1
Unspecified Tissue Injury
1
1
Partial thickness (Second Degree) Burn
1
1
Device Embedded In Tissue or Plaque
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Karl Storz Endoscopy
II
May-10-2022
2
Olympus Corporation of the Americas
II
Jun-08-2020
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