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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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
MEDIMAGING INTEGRATED SOLUTION INC. (MIIS)
  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
ZSQUARE, LTD
  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 644 644

Device Problems MDRs with this Device Problem Events in those MDRs
Break 426 426
Fluid Leak 272 272
Optical Distortion 56 56
Unintended Movement 41 41
No Display/Image 40 40
Device Reprocessing Problem 32 32
Poor Quality Image 28 28
Erratic or Intermittent Display 15 15
Crack 14 14
Fracture 14 14
Component Missing 12 12
Adverse Event Without Identified Device or Use Problem 10 10
Scratched Material 10 10
Detachment of Device or Device Component 9 9
Collapse 9 9
Failure to Clean Adequately 9 9
Material Deformation 8 8
Material Separation 8 8
Material Split, Cut or Torn 7 7
Microbial Contamination of Device 7 7
Overcorrection 7 7
Loose or Intermittent Connection 7 7
Moisture Damage 6 6
Contamination /Decontamination Problem 6 6
Obstruction of Flow 6 6
Optical Problem 6 6
Physical Resistance/Sticking 5 5
Device Fell 5 5
Device Contamination with Chemical or Other Material 5 5
Display or Visual Feedback Problem 5 5
Use of Device Problem 5 5
Smoking 4 4
Degraded 4 4
Insufficient Information 4 4
Fitting Problem 4 4
Peeled/Delaminated 4 4
Image Display Error/Artifact 4 4
Contamination 4 4
Material Fragmentation 3 3
Naturally Worn 3 3
Output Problem 3 3
Defective Device 3 3
Material Perforation 3 3
Mechanical Problem 3 3
Backflow 3 3
Delivered as Unsterile Product 3 3
Optical Obstruction 3 3
Unintended System Motion 2 2
Misfocusing 2 2
Labelling, Instructions for Use or Training Problem 2 2
Material Invagination 2 2
Signal Artifact/Noise 2 2
Optical Discoloration 2 2
Failure to Disinfect 2 2
Corroded 2 2
Detachment Of Device Component 2 2
Defective Component 2 2
Improper or Incorrect Procedure or Method 2 2
Material Integrity Problem 2 2
Excessive Heating 1 1
Electrical Shorting 1 1
Flare or Flash 1 1
Improper Device Output 1 1
Issue With Displayed Error Message 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device Inoperable 1 1
Material Discolored 1 1
Display Difficult to Read 1 1
Difficult to Fold, Unfold or Collapse 1 1
Patient Device Interaction Problem 1 1
Unexpected Shutdown 1 1
Material Opacification 1 1
Complete Blockage 1 1
Problem with Sterilization 1 1
Inaccurate Synchronization 1 1
Inadequate or Insufficient Training 1 1
Gas Leak 1 1
Material Protrusion/Extrusion 1 1
Mechanical Jam 1 1
Packaging Problem 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Appropriate Term/Code Not Available 1 1
Nonstandard Device 1 1
Overheating of Device 1 1
Shipping Damage or Problem 1 1
Increase in Suction 1 1
Residue After Decontamination 1 1
Circuit Failure 1 1
Coagulation in Device or Device Ingredient 1 1
Activation Failure 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 952 952
No Known Impact Or Consequence To Patient 54 54
No Consequences Or Impact To Patient 38 38
Insufficient Information 21 21
No Patient Involvement 18 18
Injury 7 7
Pain 4 4
Blood Loss 4 4
Anaphylactic Shock 4 4
Foreign Body In Patient 4 4
No Information 4 4
Edema 3 3
Hemorrhage/Bleeding 3 3
No Code Available 2 2
Muscle Spasm(s) 2 2
Intraoperative Pain 2 2
Burn, Thermal 2 2
Fever 2 2
Perforation 1 1
Partial thickness (Second Degree) Burn 1 1
Exposure to Body Fluids 1 1
Itching Sensation 1 1
Pleural Effusion 1 1
Pneumonia 1 1
Pneumothorax 1 1
Radiation Exposure, Unintended 1 1
Device Embedded In Tissue or Plaque 1 1
Paresis 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Abrasion 1 1
Burn(s) 1 1
Dyspnea 1 1
Hypersensitivity/Allergic reaction 1 1
Unspecified Tissue Injury 1 1
Patient Problem/Medical Problem 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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