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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
GRUMPY INNOVATION, INC.
  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
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
OPTIM, LLC
  SUBSTANTIALLY EQUIVALENT 2
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESNENT, LLC
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHUHAI WESEE MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZSQUARE, LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 47 47
2021 345 348
2022 1158 1158
2023 1352 1352
2024 1498 1498
2025 1354 1356
2026 1174 1174

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1811 1811
Fluid/Blood Leak 1322 1325
No Display/Image 765 766
Detachment of Device or Device Component 515 515
Failure to Clean Adequately 371 371
Erratic or Intermittent Display 327 327
Optical Obstruction 289 289
Device Reprocessing Problem 252 252
Peeled/Delaminated 159 159
Optical Distortion 128 128
Corroded 125 125
Poor Quality Image 95 95
Material Split, Cut or Torn 82 82
Contamination 79 79
Material Separation 75 75
Degraded 71 71
Unintended Movement 66 66
Loss of or Failure to Bond 64 64
Material Fragmentation 56 56
Crack 55 55
Residue After Decontamination 52 52
Component Missing 40 40
Optical Problem 35 35
Contamination /Decontamination Problem 30 30
Material Deformation 29 29
Microbial Contamination of Device 28 28
Fracture 23 23
Obstruction of Flow 22 22
Mechanical Problem 21 21
Display or Visual Feedback Problem 20 20
Output Problem 19 19
Moisture Damage 19 22
Scratched Material 17 17
Material Integrity Problem 16 16
Physical Resistance/Sticking 14 15
Collapse 14 14
Insufficient Information 13 13
Material Discolored 11 11
Use of Device Problem 11 11
Dent in Material 11 11
Adverse Event Without Identified Device or Use Problem 11 11
Device Fell 11 11
Overcorrection 11 11
Loose or Intermittent Connection 10 10
Misfocusing 10 10
Optical Discoloration 9 9
Communication or Transmission Problem 9 9
Device Contaminated at the User Facility 9 9
Gas/Air Leak 9 9
Overheating of Device 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6784 6789
Insufficient Information 51 51
No Consequences Or Impact To Patient 21 21
Burn(s) 17 17
No Patient Involvement 17 17
Foreign Body In Patient 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
No Known Impact Or Consequence To Patient 6 6
Discomfort 5 5
Laceration(s) 5 5
Injury 4 4
Anaphylactic Shock 4 4
Hemorrhage/Bleeding 4 4
Pain 3 3
Superficial (First Degree) Burn 2 2
Fever 2 2
Pneumonia 2 2
Unspecified Tissue Injury 2 2
Hypersensitivity/Allergic reaction 1 1
Pneumothorax 1 1
No Code Available 1 1
Transmissible Spongiform Encephalopathy(TSE) 1 1
Perforation 1 1
Burn, Thermal 1 1
Exposure to Body Fluids 1 1
Pleural Effusion 1 1
Paresis 1 1
Low Oxygen Saturation 1 1
Lethargy 1 1
Device Embedded In Tissue or Plaque 1 1
Decreased Appetite 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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