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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 2
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
  1.  K192704  Endofresh Digestive Endoscopy System
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 3270 3270

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 7507 7507
Break 2289 2289
Poor Quality Image 1987 1987
Microbial Contamination of Device 1692 1692
Fluid/Blood Leak 1617 1617
Device Reprocessing Problem 1578 1578
Obstruction of Flow 1108 1108
Contamination 808 808
Erratic or Intermittent Display 786 786
No Display/Image 659 659
Detachment of Device or Device Component 653 653
Optical Obstruction 571 571
Device Contamination with Chemical or Other Material 455 455
Contamination /Decontamination Problem 440 440
Adverse Event Without Identified Device or Use Problem 418 418
Optical Distortion 335 335
Unintended Movement 179 179
Component Missing 131 131
Material Split, Cut or Torn 90 90
Display or Visual Feedback Problem 89 89
Loose or Intermittent Connection 78 78
Image Display Error/Artifact 77 77
Partial Blockage 66 66
Mechanical Problem 61 61
Leak/Splash 54 54
Collapse 50 50
Communication or Transmission Problem 41 41
Failure to Disconnect 34 34
Fracture 34 34
Physical Resistance/Sticking 33 33
Improper or Incorrect Procedure or Method 32 32
Optical Problem 31 31
Peeled/Delaminated 28 28
Material Too Rigid or Stiff 28 28
Complete Blockage 27 27
Suction Problem 27 27
Device Damaged by Another Device 27 27
Corroded 23 23
Device Handling Problem 23 23
Loss of or Failure to Bond 22 22
Material Deformation 22 22
Insufficient Information 19 19
Scratched Material 17 17
Deformation Due to Compressive Stress 17 17
Crack 17 17
Moisture Damage 16 16
Use of Device Problem 16 16
Residue After Decontamination 14 14
Electrical /Electronic Property Problem 14 14
Failure to Disinfect 13 13
Optical Discoloration 13 13
Mechanical Jam 13 13
Dent in Material 12 12
Material Separation 11 11
Insufficient Flow or Under Infusion 11 11
Gas/Air Leak 11 11
Device Contamination with Body Fluid 10 10
Defective Component 9 9
Separation Failure 9 9
Material Protrusion/Extrusion 8 8
Material Twisted/Bent 8 8
Electrical Overstress 8 8
Degraded 8 8
Problem with Sterilization 8 8
Labelling, Instructions for Use or Training Problem 8 8
Appropriate Term/Code Not Available 8 8
Failure to Eject 7 7
Blocked Connection 7 7
Moisture or Humidity Problem 7 7
Material Integrity Problem 6 6
Infusion or Flow Problem 6 6
Sharp Edges 6 6
Device Fell 6 6
Separation Problem 6 6
Device Contaminated at the User Facility 6 6
Device Dislodged or Dislocated 5 5
Pressure Problem 5 5
Failure to Align 5 5
Material Perforation 5 5
Defective Device 4 4
Device-Device Incompatibility 4 4
Connection Problem 4 4
Ventilation Problem in Device Environment 4 4
Restricted Flow rate 4 4
Reflux within Device 4 4
Difficult to Remove 4 4
Difficult or Delayed Positioning 4 4
Material Discolored 4 4
Key or Button Unresponsive/not Working 4 4
Noise, Audible 4 4
Disconnection 3 3
Display Difficult to Read 3 3
Entrapment of Device 3 3
Flaked 3 3
Retraction Problem 3 3
Material Puncture/Hole 3 3
Difficult to Insert 3 3
Material Fragmentation 3 3
Misfocusing 3 3
Output Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 20460 20460
No Known Impact Or Consequence To Patient 1397 1397
No Consequences Or Impact To Patient 445 445
Hemorrhage/Bleeding 167 167
Perforation 159 159
Insufficient Information 157 157
Foreign Body In Patient 89 89
No Patient Involvement 85 85
Unspecified Infection 38 38
Bacterial Infection 37 37
Injury 37 37
Drug Resistant Bacterial Infection 27 27
Fever 24 24
Unspecified Hepatic or Biliary Problem 17 17
Pain 16 16
Unspecified Tissue Injury 15 15
Pancreatitis 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Laceration(s) 14 14
Abdominal Pain 14 14
Stenosis 14 14
Sepsis 12 12
Peritonitis 10 10
Abrasion 10 10
Abscess 10 10
Chest Pain 10 10
Unspecified Gastrointestinal Problem 10 10
Gastrointestinal Hemorrhage 9 9
Bowel Perforation 9 9
Chemical Exposure 8 8
Laceration(s) of Esophagus 7 7
Malaise 7 7
Chills 7 7
Pneumonia 7 7
Pneumothorax 6 6
Nausea 6 6
Muscle/Tendon Damage 6 6
Swelling/ Edema 5 5
No Code Available 5 5
Internal Organ Perforation 5 5
Death 5 5
Burn(s) 4 4
Hematoma 4 4
Fistula 4 4
Viral Infection 4 4
Therapeutic Effects, Unexpected 4 4
Respiratory Tract Infection 4 4
Perforation of Esophagus 4 4
Vomiting 4 4
Thrombosis/Thrombus 4 4
Unspecified Respiratory Problem 4 4
Hematemesis 3 3
Liver Failure 3 3
Aspiration Pneumonitis 3 3
Multiple Organ Failure 3 3
Blood Loss 3 3
Patient Problem/Medical Problem 3 3
Ulcer 3 3
Pleural Effusion 3 3
Shock 3 3
Exposure to Body Fluids 3 3
Pulmonary Embolism 3 3
Wound Dehiscence 2 2
Air Embolism 2 2
Cardiac Arrest 2 2
Aspiration/Inhalation 2 2
Eye Injury 2 2
Hyperbilirubinemia 2 2
Hyperemia 2 2
Fungal Infection 2 2
Shaking/Tremors 2 2
Abdominal Distention 2 2
Cancer 2 2
Vascular Dissection 2 2
Device Embedded In Tissue or Plaque 2 2
Transmissible Spongiform Encephalopathy(TSE) 2 2
Gastroesophageal Burn 2 2
Skin Inflammation/ Irritation 1 1
Genital Bleeding 1 1
Stenosis of the esophagus 1 1
Melena 1 1
Unspecified Eye / Vision Problem 1 1
Cough 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Embolism/Embolus 1 1
Ascites 1 1
Sore Throat 1 1
Obstruction/Occlusion 1 1
Low Oxygen Saturation 1 1
Organ Dehiscence 1 1
Numbness 1 1
Coma 1 1
Skin Irritation 1 1
Swelling 1 1
Tachycardia 1 1
Local Reaction 1 1
Tissue Damage 1 1
Urinary Tract Infection 1 1
Septic Shock 1 1
Seroma 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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