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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 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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