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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
3
AMBU A/S
SUBSTANTIALLY EQUIVALENT
3
KARL STORZ ENDOSCOPY - AMERICA, INC.
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
MEDROBOTICS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC XOMED INC.
SUBSTANTIALLY EQUIVALENT
1
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
SUBSTANTIALLY EQUIVALENT
1
OLYMPUS MEDICAL SYSTEMS CORP.
SUBSTANTIALLY EQUIVALENT
3
OPTIM, LLC
SUBSTANTIALLY EQUIVALENT
1
PENTAX MEDICAL
SUBSTANTIALLY EQUIVALENT
2
PENTAX OF AMERICA, INC.
SUBSTANTIALLY EQUIVALENT
3
SHENYANG SHENDA ENDOSCOPE CO., LTD
SUBSTANTIALLY EQUIVALENT
1
STRYKER
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
18
18
2018
23
23
2019
51
51
2020
47
47
2021
346
346
2022
350
350
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
250
250
Fluid Leak
201
201
Optical Distortion
41
41
No Display/Image
40
40
Unintended Movement
40
40
Poor Quality Image
26
26
Device Reprocessing Problem
22
22
Crack
14
14
Fracture
14
14
Erratic or Intermittent Display
13
13
Adverse Event Without Identified Device or Use Problem
10
10
Scratched Material
10
10
Material Deformation
8
8
Material Separation
8
8
Loose or Intermittent Connection
7
7
Microbial Contamination of Device
7
7
Component Missing
7
7
Detachment of Device or Device Component
7
7
Material Split, Cut or Torn
7
7
Overcorrection
6
6
Optical Problem
6
6
Moisture Damage
6
6
Collapse
6
6
Display or Visual Feedback Problem
5
5
Device Contamination with Chemical or Other Material
5
5
Contamination /Decontamination Problem
5
5
Obstruction of Flow
5
5
Use of Device Problem
5
5
Physical Resistance/Sticking
5
5
Device Fell
5
5
Failure to Clean Adequately
5
5
Insufficient Information
4
4
Fitting Problem
4
4
Smoking
4
4
Degraded
4
4
Contamination
4
4
Image Display Error/Artifact
4
4
Mechanical Problem
3
3
Material Fragmentation
3
3
Delivered as Unsterile Product
3
3
Backflow
3
3
Material Perforation
3
3
Defective Device
3
3
Optical Obstruction
3
3
Output Problem
3
3
Naturally Worn
3
3
Optical Discoloration
2
2
Peeled/Delaminated
2
2
Defective Component
2
2
Improper or Incorrect Procedure or Method
2
2
Detachment Of Device Component
2
2
Corroded
2
2
Failure to Disinfect
2
2
Unintended System Motion
2
2
Misfocusing
2
2
Labelling, Instructions for Use or Training Problem
2
2
Material Invagination
1
1
Difficult to Fold, Unfold or Collapse
1
1
Overheating of Device
1
1
Shipping Damage or Problem
1
1
Material Opacification
1
1
Display Difficult to Read
1
1
Material Discolored
1
1
Complete Blockage
1
1
Coagulation in Device or Device Ingredient
1
1
Signal Artifact/Noise
1
1
Circuit Failure
1
1
Problem with Sterilization
1
1
Increase in Suction
1
1
Inaccurate Synchronization
1
1
Inadequate or Insufficient Training
1
1
Device Inoperable
1
1
Electrical Shorting
1
1
Flare or Flash
1
1
Residue After Decontamination
1
1
Packaging Problem
1
1
Gas Leak
1
1
Improper Device Output
1
1
Issue With Displayed Error Message
1
1
Device Contaminated During Manufacture or Shipping
1
1
Material Integrity Problem
1
1
Material Protrusion/Extrusion
1
1
Mechanical Jam
1
1
Therapeutic or Diagnostic Output Failure
1
1
Appropriate Term/Code Not Available
1
1
Activation Failure
1
1
Patient Device Interaction Problem
1
1
Unexpected Shutdown
1
1
Excessive Heating
1
1
Application Program Freezes, Becomes Nonfunctional
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
662
662
No Known Impact Or Consequence To Patient
54
54
No Consequences Or Impact To Patient
38
38
Insufficient Information
20
20
No Patient Involvement
18
18
Injury
7
7
Anaphylactic Shock
4
4
Blood Loss
4
4
Foreign Body In Patient
4
4
No Information
4
4
Edema
3
3
Hemorrhage/Bleeding
3
3
Pain
3
3
Burn, Thermal
2
2
Intraoperative Pain
2
2
Muscle Spasm(s)
2
2
Fever
2
2
No Code Available
2
2
Patient Problem/Medical Problem
1
1
Partial thickness (Second Degree) Burn
1
1
Radiation Exposure, Unintended
1
1
Device Embedded In Tissue or Plaque
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Exposure to Body Fluids
1
1
Dyspnea
1
1
Abrasion
1
1
Hypersensitivity/Allergic reaction
1
1
Itching Sensation
1
1
Paresis
1
1
Perforation
1
1
Pleural Effusion
1
1
Pneumonia
1
1
Pneumothorax
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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