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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)
Regulation Description Nasopharyngoscope (flexible or rigid) and accessories.
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
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 SE & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
MEDICALTEK CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDIMAGING INTEGRATED SOLUTION INC. (MIIS)
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 2
OPTIM, LLC
  SUBSTANTIALLY EQUIVALENT 1
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZSQUARE, LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 47 47
2021 346 346
2022 1158 1158
2023 1353 1353
2024 1498 1498
2025 99 99

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1501 1501
Fluid/Blood Leak 1103 1103
No Display/Image 479 479
Erratic or Intermittent Display 259 259
Optical Obstruction 225 225
Detachment of Device or Device Component 140 140
Optical Distortion 121 121
Failure to Clean Adequately 107 107
Device Reprocessing Problem 106 106
Unintended Movement 63 63
Peeled/Delaminated 46 46
Material Split, Cut or Torn 33 33
Poor Quality Image 33 33
Crack 23 23
Material Separation 23 23
Microbial Contamination of Device 22 22
Contamination 17 17
Component Missing 17 17
Obstruction of Flow 16 16
Mechanical Problem 15 15
Fracture 14 14
Collapse 11 11
Optical Problem 11 11
Overcorrection 11 11
Adverse Event Without Identified Device or Use Problem 10 10
Degraded 10 10
Optical Discoloration 8 8
Scratched Material 8 8
Material Integrity Problem 8 8
Contamination /Decontamination Problem 8 8
Misfocusing 7 7
Material Fragmentation 6 6
Insufficient Information 6 6
Physical Resistance/Sticking 6 6
Display or Visual Feedback Problem 6 6
Device Fell 5 5
Moisture Damage 5 5
Use of Device Problem 5 5
Overheating of Device 5 5
Material Deformation 4 4
Loose or Intermittent Connection 4 4
Fitting Problem 4 4
Defective Device 4 4
Defective Component 4 4
Delivered as Unsterile Product 3 3
Unsealed Device Packaging 3 3
Material Perforation 3 3
Improper or Incorrect Procedure or Method 3 3
Backflow 3 3
Gas/Air Leak 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4398 4398
Insufficient Information 28 28
No Consequences Or Impact To Patient 21 21
No Patient Involvement 17 17
Burn(s) 7 7
No Known Impact Or Consequence To Patient 6 6
Discomfort 5 5
Anaphylactic Shock 4 4
Hemorrhage/Bleeding 4 4
Foreign Body In Patient 4 4
Injury 4 4
Laceration(s) 2 2
Pain 2 2
Pneumonia 2 2
Fever 2 2
Superficial (First Degree) Burn 2 2
Paresis 1 1
Perforation 1 1
Pleural Effusion 1 1
Pneumothorax 1 1
Exposure to Body Fluids 1 1
Hypersensitivity/Allergic reaction 1 1
Transmissible Spongiform Encephalopathy(TSE) 1 1
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
No Code Available 1 1
Low Oxygen Saturation 1 1
Burn, Thermal 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Karl Storz Endoscopy II May-10-2022
2 Olympus Corporation of the Americas II May-23-2024
3 Olympus Corporation of the Americas II Mar-22-2024
4 Olympus Corporation of the Americas II Jun-08-2020
5 Shirakawa Olympus Co., Ltd. II Jan-09-2024
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