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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 10
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 1
HUIZHOU XZING TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEPTUNE MEDICAL, INC.
  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
VISURA TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 178 178
2018 304 304
2019 1376 1376
2020 601 601
2021 1755 1755
2022 4526 4526

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 1526 1526
Break 1357 1357
Microbial Contamination of Device 1298 1298
Fluid/Blood Leak 682 682
Device Reprocessing Problem 539 539
Contamination 439 439
Obstruction of Flow 415 415
Device Contamination with Chemical or Other Material 357 357
Adverse Event Without Identified Device or Use Problem 297 297
Detachment of Device or Device Component 289 289
Contamination /Decontamination Problem 282 282
Poor Quality Image 273 273
Optical Distortion 259 259
Unintended Movement 160 160
No Display/Image 154 154
Component Missing 108 108
Material Split, Cut or Torn 70 70
Loose or Intermittent Connection 46 46
Collapse 42 42
Erratic or Intermittent Display 40 40
Partial Blockage 38 38
Display or Visual Feedback Problem 33 33
Leak/Splash 33 33
Fracture 33 33
Failure to Disconnect 30 30
Mechanical Problem 28 28
Optical Problem 26 26
Physical Resistance/Sticking 24 24
Image Display Error/Artifact 23 23
Loss of or Failure to Bond 22 22
Material Deformation 22 22
Device Damaged by Another Device 22 22
Insufficient Information 22 22
Device Handling Problem 20 20
Improper or Incorrect Procedure or Method 19 19
Suction Problem 19 19
Appropriate Term/Code Not Available 19 19
Corroded 18 18
Use of Device Problem 17 17
Moisture Damage 14 14
Complete Blockage 14 14
Failure to Disinfect 12 12
Material Too Rigid or Stiff 12 12
Peeled/Delaminated 11 11
Electrical /Electronic Property Problem 11 11
Failure to Align 11 11
Optical Discoloration 10 10
Scratched Material 10 10
Gas/Air Leak 10 10
Dent in Material 9 9
Degraded 9 9
Crack 8 8
Deformation Due to Compressive Stress 8 8
Separation Failure 8 8
Residue After Decontamination 8 8
Electrical Overstress 8 8
Mechanical Jam 8 8
Moisture or Humidity Problem 7 7
Device Dislodged or Dislocated 7 7
Reflux within Device 7 7
Labelling, Instructions for Use or Training Problem 7 7
Failure to Eject 7 7
Device Fell 7 7
Device Contaminated at the User Facility 6 6
Problem with Sterilization 6 6
Communication or Transmission Problem 6 6
Material Perforation 5 5
Material Separation 5 5
Infusion or Flow Problem 5 5
Material Integrity Problem 5 5
Noise, Audible 5 5
Material Twisted/Bent 5 5
Separation Problem 4 4
Ventilation Problem in Device Environment 4 4
Device Contamination with Body Fluid 4 4
Defective Device 4 4
Difficult or Delayed Positioning 4 4
Disconnection 4 4
Material Discolored 3 3
Sticking 3 3
Difficult to Remove 3 3
Misfocusing 3 3
Flaked 3 3
Material Fragmentation 3 3
Connection Problem 3 3
Device-Device Incompatibility 3 3
Defective Component 3 3
Insufficient Flow or Under Infusion 3 3
Output Problem 3 3
Material Protrusion/Extrusion 3 3
Naturally Worn 3 3
Blocked Connection 3 3
Difficult to Open or Close 3 3
Key or Button Unresponsive/not Working 3 3
Excessive Heating 2 2
Free or Unrestricted Flow 2 2
Temperature Problem 2 2
Solder Joint Fracture 2 2
Difficult to Advance 2 2
Restricted Flow rate 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5898 5898
No Known Impact Or Consequence To Patient 1735 1735
No Consequences Or Impact To Patient 506 506
Insufficient Information 144 144
No Patient Involvement 107 107
Perforation 101 101
Hemorrhage/Bleeding 92 92
Injury 41 41
Unspecified Infection 32 32
Foreign Body In Patient 31 31
No Code Available 16 16
Bacterial Infection 15 15
Inflammation 14 14
Pain 12 12
Laceration(s) 11 11
Unspecified Hepatic or Biliary Problem 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Drug Resistant Bacterial Infection 8 8
Unspecified Tissue Injury 8 8
Abscess 8 8
Abdominal Pain 8 8
Peritonitis 8 8
Stenosis 8 8
Sepsis 8 8
Laceration(s) of Esophagus 7 7
Fever 7 7
Pancreatitis 7 7
Unspecified Gastrointestinal Problem 7 7
Pneumonia 6 6
Abrasion 5 5
Death 5 5
Perforation of Esophagus 5 5
Bowel Perforation 5 5
Vomiting 5 5
Blood Loss 5 5
Chemical Exposure 4 4
Patient Problem/Medical Problem 4 4
Respiratory Tract Infection 4 4
Therapeutic Effects, Unexpected 4 4
Pneumothorax 4 4
Fistula 4 4
Thrombosis/Thrombus 4 4
Unspecified Respiratory Problem 4 4
Muscle/Tendon Damage 4 4
No Information 3 3
Swelling/ Edema 3 3
Gastrointestinal Hemorrhage 3 3
Aspiration Pneumonitis 3 3
Chest Pain 3 3
Pleural Effusion 3 3
Shock 3 3
Burn(s) 3 3
Cardiac Arrest 2 2
Hypersensitivity/Allergic reaction 2 2
Wound Dehiscence 2 2
Pulmonary Embolism 2 2
Air Embolism 2 2
Vascular Dissection 2 2
Device Embedded In Tissue or Plaque 2 2
Shaking/Tremors 2 2
Liver Failure 2 2
Stenosis of the esophagus 1 1
Hematemesis 1 1
Genital Bleeding 1 1
Joint Dislocation 1 1
Sore Throat 1 1
Ascites 1 1
Abdominal Distention 1 1
Multiple Organ Failure 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Tissue Damage 1 1
Urinary Tract Infection 1 1
Seroma 1 1
Ulcer 1 1
Discomfort 1 1
Obstruction/Occlusion 1 1
Needle Stick/Puncture 1 1
Low Oxygen Saturation 1 1
Organ Dehiscence 1 1
Numbness 1 1
Coma 1 1
Airway Obstruction 1 1
Exposure to Body Fluids 1 1
Bradycardia 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Hypovolemic Shock 1 1
Cellulitis 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Embolism 1 1
Skin Irritation 1 1
Swelling 1 1
Tachycardia 1 1
Local Reaction 1 1
Damage to Ligament(s) 1 1
Liver Damage/Dysfunction 1 1
Myocardial Infarction 1 1
Internal Organ Perforation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Fujifilm Medical Systems U.S.A., Inc. II Jul-10-2017
2 Olympus Corporation of the Americas II Jun-21-2022
3 Olympus Corporation of the Americas II Nov-27-2020
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