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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
SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 628 628

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1303 1303
Fluid/Blood Leak 892 892
No Display/Image 269 269
Erratic or Intermittent Display 200 200
Optical Obstruction 142 142
Optical Distortion 118 118
Detachment of Device or Device Component 94 94
Device Reprocessing Problem 76 76
Failure to Clean Adequately 71 71
Unintended Movement 54 54
Peeled/Delaminated 38 38
Poor Quality Image 33 33
Microbial Contamination of Device 26 26
Material Split, Cut or Torn 22 22
Material Separation 21 21
Crack 21 21
Contamination 17 17
Component Missing 17 17
Obstruction of Flow 14 14
Fracture 14 14
Mechanical Problem 13 13
Collapse 11 11
Overcorrection 11 11
Degraded 10 10
Optical Problem 9 9
Adverse Event Without Identified Device or Use Problem 9 9
Optical Discoloration 7 7
Material Deformation 7 7
Material Integrity Problem 7 7
Physical Resistance/Sticking 7 7
Scratched Material 7 7
Misfocusing 7 7
Contamination /Decontamination Problem 7 7
Moisture Damage 6 6
Loose or Intermittent Connection 5 5
Display or Visual Feedback Problem 5 5
Overheating of Device 5 5
Use of Device Problem 5 5
Device Fell 5 5
Insufficient Information 5 5
Device Contamination with Chemical or Other Material 4 4
Improper or Incorrect Procedure or Method 4 4
Fitting Problem 4 4
Defective Device 4 4
Defective Component 4 4
Material Fragmentation 4 4
Image Display Error/Artifact 3 3
Delivered as Unsterile Product 3 3
Backflow 3 3
Material Perforation 3 3
Naturally Worn 3 3
Separation Problem 3 3
Device Contaminated During Manufacture or Shipping 2 2
Output Problem 2 2
Unsealed Device Packaging 2 2
Connection Problem 2 2
Unintended System Motion 2 2
Material Rupture 2 2
Signal Artifact/Noise 2 2
Disconnection 2 2
Failure to Disinfect 2 2
Labelling, Instructions for Use or Training Problem 2 2
Material Invagination 2 2
Corroded 2 2
Fogging 1 1
Difficult to Fold, Unfold or Collapse 1 1
Material Frayed 1 1
Material Opacification 1 1
Nonstandard Device 1 1
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
Failure to Advance 1 1
Dent in Material 1 1
Residue After Decontamination 1 1
Dull, Blunt 1 1
Device Dislodged or Dislocated 1 1
Flare or Flash 1 1
Sparking 1 1
Blocked Connection 1 1
Communication or Transmission Problem 1 1
Material Puncture/Hole 1 1
Device Damaged Prior to Use 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
Packaging Problem 1 1
Gas/Air Leak 1 1
Material Protrusion/Extrusion 1 1
Mechanical Jam 1 1
Moisture or Humidity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3437 3437
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
Burn(s) 5 5
Anaphylactic Shock 4 4
Pain 4 4
Blood Loss 3 3
Muscle Spasm(s) 2 2
Pneumonia 2 2
Fever 2 2
Hemorrhage/Bleeding 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
Hypersensitivity/Allergic reaction 1 1
Itching Sensation 1 1
Exposure to Body Fluids 1 1
Dyspnea 1 1
Edema 1 1
Pneumothorax 1 1
Abrasion 1 1
Paresis 1 1
Perforation 1 1
Pleural Effusion 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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