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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 CodeEOB
Regulation Number 874.4760
Device Class 2


Premarket Reviews
ManufacturerDecision
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 211 211

Device Problems MDRs with this Device Problem Events in those MDRs
Break 850 850
Fluid/Blood Leak 429 429
Optical Distortion 97 97
Unintended Movement 43 43
No Display/Image 43 43
Device Reprocessing Problem 36 36
Poor Quality Image 28 28
Detachment of Device or Device Component 28 28
Optical Obstruction 17 17
Peeled/Delaminated 16 16
Crack 16 16
Contamination 15 15
Microbial Contamination of Device 15 15
Component Missing 15 15
Erratic or Intermittent Display 14 14
Fracture 13 13
Material Separation 11 11
Scratched Material 11 11
Failure to Clean Adequately 10 10
Collapse 10 10
Obstruction of Flow 9 9
Degraded 8 8
Loose or Intermittent Connection 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Overcorrection 7 7
Material Split, Cut or Torn 7 7
Physical Resistance/Sticking 7 7
Mechanical Problem 7 7
Misfocusing 6 6
Moisture Damage 6 6
Contamination /Decontamination Problem 6 6
Optical Problem 6 6
Device Fell 5 5
Device Contamination with Chemical or Other Material 5 5
Material Deformation 5 5
Use of Device Problem 5 5
Fitting Problem 4 4
Image Display Error/Artifact 4 4
Display or Visual Feedback Problem 4 4
Insufficient Information 4 4
Optical Discoloration 3 3
Naturally Worn 3 3
Delivered as Unsterile Product 3 3
Backflow 3 3
Material Perforation 3 3
Defective Device 3 3
Improper or Incorrect Procedure or Method 3 3
Unsealed Device Packaging 2 2
Unintended System Motion 2 2
Defective Component 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 Fragmentation 2 2
Device Contaminated During Manufacture or Shipping 2 2
Output Problem 2 2
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
Application Program Freezes, Becomes Nonfunctional 1 1
Material Frayed 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
Residue After Decontamination 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
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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1682 1682
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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