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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device gastroscope and accessories, flexible/rigid
Definition To examine or perform procedures in the stomach. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data 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 CodeFDS
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
AMBU A/S
  SUBSTANTIALLY EQUIVALENT 1
EVOENDO INC
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
FUJIFILM CORPORATON
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM HEALTHCARE AMERICAS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HUIZHOU XZING TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
IQ ENDOSCOPES LIMITED
  SUBSTANTIALLY EQUIVALENT 1
NEPTUNE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2019 1376 1376
2020 601 601
2021 1755 1755
2022 6216 6216
2023 9873 9873
2024 875 875

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 5967 5967
Break 2274 2274
Poor Quality Image 1962 1962
Microbial Contamination of Device 1588 1588
Fluid/Blood Leak 1497 1497
Device Reprocessing Problem 1455 1455
Obstruction of Flow 1025 1025
Contamination 804 804
Erratic or Intermittent Display 652 652
Detachment of Device or Device Component 618 618
No Display/Image 566 566
Optical Obstruction 499 499
Device Contamination with Chemical or Other Material 454 454
Contamination /Decontamination Problem 423 423
Adverse Event Without Identified Device or Use Problem 398 398
Optical Distortion 335 335
Unintended Movement 177 177
Component Missing 131 131
Display or Visual Feedback Problem 89 89
Material Split, Cut or Torn 87 87
Loose or Intermittent Connection 75 75
Image Display Error/Artifact 75 75
Partial Blockage 64 64
Mechanical Problem 61 61
Collapse 50 50
Leak/Splash 49 49
Communication or Transmission Problem 38 38
Failure to Disconnect 34 34
Fracture 33 33
Optical Problem 31 31
Physical Resistance/Sticking 31 31
Improper or Incorrect Procedure or Method 30 30
Suction Problem 27 27
Peeled/Delaminated 27 27
Complete Blockage 26 26
Material Too Rigid or Stiff 26 26
Device Damaged by Another Device 25 25
Device Handling Problem 23 23
Material Deformation 22 22
Loss of or Failure to Bond 22 22
Corroded 22 22
Insufficient Information 18 18
Moisture Damage 16 16
Scratched Material 16 16
Use of Device Problem 16 16
Deformation Due to Compressive Stress 15 15
Residue After Decontamination 14 14
Electrical /Electronic Property Problem 14 14
Crack 14 14
Failure to Disinfect 13 13
Mechanical Jam 13 13
Dent in Material 12 12
Optical Discoloration 12 12
Gas/Air Leak 11 11
Insufficient Flow or Under Infusion 11 11
Material Separation 10 10
Separation Failure 9 9
Device Contamination with Body Fluid 9 9
Defective Component 9 9
Problem with Sterilization 8 8
Material Twisted/Bent 8 8
Degraded 8 8
Electrical Overstress 8 8
Labelling, Instructions for Use or Training Problem 8 8
Blocked Connection 7 7
Moisture or Humidity Problem 7 7
Failure to Eject 7 7
Appropriate Term/Code Not Available 7 7
Infusion or Flow Problem 6 6
Device Contaminated at the User Facility 6 6
Device Fell 6 6
Material Integrity Problem 6 6
Sharp Edges 6 6
Separation Problem 6 6
Material Protrusion/Extrusion 6 6
Pressure Problem 5 5
Failure to Align 5 5
Material Perforation 5 5
Device Dislodged or Dislocated 5 5
Ventilation Problem in Device Environment 4 4
Connection Problem 4 4
Difficult or Delayed Positioning 4 4
Key or Button Unresponsive/not Working 4 4
Noise, Audible 4 4
Defective Device 4 4
Restricted Flow rate 4 4
Device-Device Incompatibility 4 4
Reflux within Device 4 4
Material Fragmentation 3 3
Entrapment of Device 3 3
Disconnection 3 3
Flaked 3 3
Misfocusing 3 3
Output Problem 3 3
Naturally Worn 3 3
Difficult to Open or Close 3 3
Material Puncture/Hole 3 3
Retraction Problem 3 3
Particulates 3 3
Display Difficult to Read 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18097 18097
No Known Impact Or Consequence To Patient 1397 1397
No Consequences Or Impact To Patient 445 445
Insufficient Information 155 155
Hemorrhage/Bleeding 154 154
Perforation 149 149
Foreign Body In Patient 86 86
No Patient Involvement 85 85
Unspecified Infection 38 38
Injury 37 37
Bacterial Infection 29 29
Drug Resistant Bacterial Infection 27 27
Fever 22 22
Pancreatitis 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Unspecified Tissue Injury 15 15
Unspecified Hepatic or Biliary Problem 15 15
Abdominal Pain 14 14
Laceration(s) 14 14
Pain 14 14
Stenosis 11 11
Sepsis 11 11
Abrasion 10 10
Peritonitis 10 10
Unspecified Gastrointestinal Problem 9 9
Gastrointestinal Hemorrhage 9 9
Chemical Exposure 8 8
Abscess 8 8
Laceration(s) of Esophagus 7 7
Pneumonia 7 7
Malaise 7 7
Chills 7 7
Bowel Perforation 6 6
Pneumothorax 6 6
Chest Pain 6 6
Swelling/ Edema 5 5
No Code Available 5 5
Death 5 5
Nausea 4 4
Thrombosis/Thrombus 4 4
Burn(s) 4 4
Perforation of Esophagus 4 4
Muscle/Tendon Damage 4 4
Therapeutic Effects, Unexpected 4 4
Unspecified Respiratory Problem 4 4
Respiratory Tract Infection 4 4
Viral Infection 4 4
Hematoma 4 4
Vomiting 4 4
Fistula 4 4
Blood Loss 3 3
Aspiration Pneumonitis 3 3
Liver Failure 3 3
Patient Problem/Medical Problem 3 3
Ulcer 3 3
Exposure to Body Fluids 3 3
Pleural Effusion 3 3
Multiple Organ Failure 3 3
Pulmonary Embolism 3 3
Hematemesis 3 3
Internal Organ Perforation 3 3
Shock 3 3
Hyperemia 2 2
Aspiration/Inhalation 2 2
Eye Injury 2 2
Vascular Dissection 2 2
Fungal Infection 2 2
Wound Dehiscence 2 2
Air Embolism 2 2
Cancer 2 2
Abdominal Distention 2 2
Device Embedded In Tissue or Plaque 2 2
Shaking/Tremors 2 2
Cardiac Arrest 2 2
Stenosis of the esophagus 1 1
Embolism 1 1
Pyrosis/Heartburn 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Numbness 1 1
Dysphagia/ Odynophagia 1 1
Melena 1 1
Skin Irritation 1 1
High Blood Pressure/ Hypertension 1 1
Obstruction/Occlusion 1 1
Gastroesophageal Burn 1 1
Urinary Tract Infection 1 1
Seroma 1 1
Local Reaction 1 1
Liver Damage/Dysfunction 1 1
Myocardial Infarction 1 1
Hypersensitivity/Allergic reaction 1 1
Low Oxygen Saturation 1 1
Transmissible Spongiform Encephalopathy(TSE) 1 1
Low Blood Pressure/ Hypotension 1 1
Unspecified Eye / Vision Problem 1 1
Genital Bleeding 1 1
Hypovolemic Shock 1 1
Anemia 1 1
Cough 1 1
Coma 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aomori Olympus Co., Ltd. II Sep-07-2023
2 Olympus Corporation of the Americas II Jun-21-2022
3 Olympus Corporation of the Americas II Nov-27-2020
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