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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 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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