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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 2
ATMOS MEDIZINTECHNIK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
H&A MUI ENTERPRISES INC.
  SUBSTANTIALLY EQUIVALENT 1
HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ ENDOSCOPY - AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY-AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ SE & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
MEDIMAGING INTEGRATED SOLUTION INC. (MIIS)
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 4
OPTIM, LLC
  SUBSTANTIALLY EQUIVALENT 1
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 3
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
ZSQUARE, LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 51 51
2020 47 47
2021 346 346
2022 1158 1158
2023 1353 1353
2024 120 120

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1191 1191
Fluid/Blood Leak 762 762
No Display/Image 187 187
Erratic or Intermittent Display 139 139
Optical Distortion 115 115
Optical Obstruction 111 111
Detachment of Device or Device Component 75 75
Device Reprocessing Problem 64 64
Unintended Movement 53 53
Failure to Clean Adequately 41 41
Peeled/Delaminated 35 35
Poor Quality Image 31 31
Microbial Contamination of Device 25 25
Material Separation 19 19
Crack 18 18
Contamination 17 17
Material Split, Cut or Torn 17 17
Component Missing 16 16
Fracture 14 14
Mechanical Problem 13 13
Obstruction of Flow 13 13
Collapse 11 11
Degraded 9 9
Optical Problem 9 9
Overcorrection 9 9
Adverse Event Without Identified Device or Use Problem 9 9
Optical Discoloration 7 7
Scratched Material 7 7
Physical Resistance/Sticking 7 7
Misfocusing 7 7
Contamination /Decontamination Problem 7 7
Moisture Damage 6 6
Loose or Intermittent Connection 5 5
Use of Device Problem 5 5
Device Fell 5 5
Insufficient Information 5 5
Material Deformation 5 5
Improper or Incorrect Procedure or Method 4 4
Fitting Problem 4 4
Device Contamination with Chemical or Other Material 4 4
Defective Device 4 4
Material Fragmentation 4 4
Display or Visual Feedback Problem 4 4
Backflow 3 3
Image Display Error/Artifact 3 3
Delivered as Unsterile Product 3 3
Material Perforation 3 3
Defective Component 3 3
Overheating of Device 3 3
Material Integrity Problem 3 3
Naturally Worn 3 3
Device Contaminated During Manufacture or Shipping 2 2
Separation Problem 2 2
Unsealed Device Packaging 2 2
Unintended System Motion 2 2
Connection Problem 2 2
Labelling, Instructions for Use or Training Problem 2 2
Material Invagination 2 2
Corroded 2 2
Signal Artifact/Noise 2 2
Disconnection 2 2
Failure to Disinfect 2 2
Display Difficult to Read 1 1
Application Program Problem: Dose Calculation Error 1 1
Flaked 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
Fogging 1 1
Difficult to Fold, Unfold or Collapse 1 1
Material Frayed 1 1
Material Opacification 1 1
Nonstandard Device 1 1
Communication or Transmission Problem 1 1
Gas/Air Leak 1 1
Flare or Flash 1 1
Sparking 1 1
Blocked Connection 1 1
Failure to Advance 1 1
Dent in Material 1 1
Residue After Decontamination 1 1
Dull, Blunt 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
Unraveled Material 1 1
Unstable 1 1
Device Handling Problem 1 1
Activation Failure 1 1
Noise, Audible 1 1
Patient Device Interaction Problem 1 1
Unexpected Shutdown 1 1
Excessive Heating 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Material Protrusion/Extrusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2929 2929
No Consequences Or Impact To Patient 35 35
No Known Impact Or Consequence To Patient 29 29
Insufficient Information 27 27
No Patient Involvement 17 17
Injury 7 7
Discomfort 5 5
Foreign Body In Patient 5 5
Anaphylactic Shock 4 4
Pain 4 4
Burn(s) 3 3
Blood Loss 3 3
Fever 2 2
Hemorrhage/Bleeding 2 2
Muscle Spasm(s) 2 2
Pneumonia 2 2
Intraoperative Pain 2 2
No Information 2 2
No Code Available 2 2
Unspecified Tissue Injury 1 1
Decreased Appetite 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Device Embedded In Tissue or Plaque 1 1
Patient Problem/Medical Problem 1 1
Low Oxygen Saturation 1 1
Burn, Thermal 1 1
Pneumothorax 1 1
Abrasion 1 1
Paresis 1 1
Perforation 1 1
Pleural Effusion 1 1
Hypersensitivity/Allergic reaction 1 1
Itching Sensation 1 1
Dyspnea 1 1
Edema 1 1
Exposure to Body Fluids 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
3 Shirakawa Olympus Co., Ltd. II Jan-09-2024
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