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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
EASYGLIDE LTD.
  SUBSTANTIALLY EQUIVALENT 2
ENDOCHOICE INC.
  SUBSTANTIALLY EQUIVALENT 1
ENDOCHOICE, INC.
  SUBSTANTIALLY EQUIVALENT 1
EVOENDO INC
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 10
FUJIFILM CORPORATON
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM HEALTHCARE AMERICAS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 2
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJINON INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJINON, INC.
  SUBSTANTIALLY EQUIVALENT 1
GI SCIENTIFIC LLC
  SUBSTANTIALLY EQUIVALENT 1
HUIZHOU XZING TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
IQ ENDOSCOPES LIMITED
  SUBSTANTIALLY EQUIVALENT 1
NEPTUNE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PENTAX MEDICAL COMPANY
  SUBSTANTIALLY EQUIVALENT 1
PENTAX MEDICAL OF AMERICA, INC
  SUBSTANTIALLY EQUIVALENT 1
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 3
SUMITOMO BAKELITE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES ENDOSCOPY GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
VISURA TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 23 23
2015 28 28
2016 108 108
2017 178 178
2018 304 304
2019 1376 1376
2020 601 601
2021 1755 1755
2022 6216 6216
2023 9873 9873
2024 2562 2562

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 7020 7020
Break 2298 2298
Microbial Contamination of Device 2018 2018
Poor Quality Image 1982 1982
Fluid/Blood Leak 1603 1603
Device Reprocessing Problem 1586 1586
Obstruction of Flow 1102 1102
Contamination 810 810
Erratic or Intermittent Display 755 755
No Display/Image 652 652
Detachment of Device or Device Component 649 649
Optical Obstruction 559 559
Device Contamination with Chemical or Other Material 469 469
Adverse Event Without Identified Device or Use Problem 460 460
Contamination /Decontamination Problem 448 448
Optical Distortion 335 335
Unintended Movement 178 178
Component Missing 131 131
Display or Visual Feedback Problem 90 90
Material Split, Cut or Torn 88 88
Image Display Error/Artifact 80 80
Loose or Intermittent Connection 78 78
Partial Blockage 69 69
Mechanical Problem 62 62
Leak/Splash 58 58
Collapse 50 50
Communication or Transmission Problem 41 41
Improper or Incorrect Procedure or Method 37 37
Failure to Disconnect 34 34
Fracture 34 34
Physical Resistance/Sticking 33 33
Optical Problem 31 31
Insufficient Information 29 29
Peeled/Delaminated 28 28
Complete Blockage 28 28
Suction Problem 28 28
Material Too Rigid or Stiff 28 28
Device Damaged by Another Device 27 27
Device Handling Problem 27 27
Material Deformation 25 25
Corroded 23 23
Loss of or Failure to Bond 22 22
Appropriate Term/Code Not Available 21 21
Mechanical Jam 18 18
Use of Device Problem 18 18
Scratched Material 17 17
Moisture Damage 16 16
Crack 16 16
Electrical /Electronic Property Problem 15 15
Deformation Due to Compressive Stress 15 15
Residue After Decontamination 14 14
Degraded 14 14
Failure to Disinfect 13 13
Optical Discoloration 13 13
Failure to Align 12 12
Dent in Material 12 12
Insufficient Flow or Under Infusion 11 11
Gas/Air Leak 11 11
Material Separation 10 10
Device Contamination with Body Fluid 10 10
Defective Component 9 9
Separation Failure 9 9
Material Protrusion/Extrusion 9 9
Connection Problem 9 9
Labelling, Instructions for Use or Training Problem 9 9
Device Dislodged or Dislocated 8 8
Electrical Overstress 8 8
Material Twisted/Bent 8 8
Problem with Sterilization 8 8
Sticking 7 7
Material Integrity Problem 7 7
Moisture or Humidity Problem 7 7
Infusion or Flow Problem 7 7
Blocked Connection 7 7
Reflux within Device 7 7
Failure to Eject 7 7
Device Fell 7 7
Sharp Edges 6 6
Separation Problem 6 6
Device Contaminated at the User Facility 6 6
Difficult to Remove 6 6
Overheating of Device 6 6
Difficult to Insert 6 6
Material Fragmentation 5 5
Misconnection 5 5
Material Perforation 5 5
Device Issue 5 5
Noise, Audible 5 5
Pressure Problem 5 5
Output Problem 4 4
Ventilation Problem in Device Environment 4 4
Key or Button Unresponsive/not Working 4 4
Defective Device 4 4
Device-Device Incompatibility 4 4
Difficult to Open or Close 4 4
Restricted Flow rate 4 4
Difficult or Delayed Positioning 4 4
Material Discolored 4 4
Disconnection 4 4
Entrapment of Device 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19757 19757
No Known Impact Or Consequence To Patient 1766 1766
No Consequences Or Impact To Patient 558 558
Hemorrhage/Bleeding 173 173
Perforation 168 168
Insufficient Information 157 157
No Patient Involvement 134 134
Foreign Body In Patient 106 106
Bacterial Infection 56 56
Injury 44 44
Unspecified Infection 40 40
Drug Resistant Bacterial Infection 27 27
Fever 26 26
Unspecified Hepatic or Biliary Problem 17 17
No Code Available 17 17
Laceration(s) 16 16
Abdominal Pain 16 16
Pain 16 16
Pancreatitis 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Unspecified Tissue Injury 15 15
Stenosis 14 14
Inflammation 14 14
No Information 13 13
Sepsis 12 12
Abrasion 11 11
Bowel Perforation 11 11
Peritonitis 10 10
Abscess 10 10
Chest Pain 10 10
Gastrointestinal Hemorrhage 9 9
Unspecified Gastrointestinal Problem 9 9
Chemical Exposure 8 8
Chills 8 8
Laceration(s) of Esophagus 8 8
Malaise 7 7
Pneumonia 7 7
Death 7 7
Burn(s) 7 7
Pneumothorax 6 6
Nausea 6 6
Perforation of Esophagus 6 6
Muscle/Tendon Damage 6 6
Swelling/ Edema 5 5
Blood Loss 5 5
Vomiting 5 5
Internal Organ Perforation 5 5
Exposure to Body Fluids 5 5
Diarrhea 4 4
Fistula 4 4
Hematoma 4 4
Therapeutic Effects, Unexpected 4 4
Tissue Damage 4 4
Viral Infection 4 4
Respiratory Tract Infection 4 4
Thrombosis/Thrombus 4 4
Unspecified Respiratory Problem 4 4
Patient Problem/Medical Problem 4 4
Multiple Organ Failure 3 3
Aspiration Pneumonitis 3 3
Hematemesis 3 3
Fungal Infection 3 3
Ulcer 3 3
Liver Failure 3 3
Shock 3 3
Pleural Effusion 3 3
Hypersensitivity/Allergic reaction 3 3
Air Embolism 3 3
Pulmonary Embolism 3 3
Aspiration/Inhalation 2 2
Wound Dehiscence 2 2
Cardiac Arrest 2 2
Eye Injury 2 2
Hyperbilirubinemia 2 2
Hyperemia 2 2
Burning Sensation 2 2
Abdominal Distention 2 2
Shaking/Tremors 2 2
Electric Shock 2 2
Cancer 2 2
Vascular Dissection 2 2
Device Embedded In Tissue or Plaque 2 2
Unspecified Mental, Emotional or Behavioural Problem 1 1
Embolism/Embolus 1 1
Melena 1 1
Stenosis of the esophagus 1 1
Cough 1 1
Unspecified Eye / Vision Problem 1 1
Gastroesophageal Burn 1 1
Ascites 1 1
Discomfort 1 1
Obstruction/Occlusion 1 1
Needle Stick/Puncture 1 1
Low Oxygen Saturation 1 1
Organ Dehiscence 1 1
Genital Bleeding 1 1
Skin Inflammation/ Irritation 1 1
Transmissible Spongiform Encephalopathy(TSE) 1 1
Mediastinal Shift 1 1
Excessive Tear Production 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aomori Olympus Co., Ltd. II Sep-07-2023
2 Fujifilm Medical Systems U.S.A., Inc. II Jul-10-2017
3 Fujinon Inc II Oct-30-2013
4 Olympus Corporation of the Americas II Jun-21-2022
5 Olympus Corporation of the Americas II Nov-27-2020
6 Pentax Medical Company II Jun-28-2016
7 Pentax Medical Company II Jul-24-2014
8 Pentax of America Inc II Oct-26-2016
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