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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
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 2562 2562

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 7020 7020
Break 2289 2289
Poor Quality Image 1982 1982
Microbial Contamination of Device 1656 1656
Fluid/Blood Leak 1595 1595
Device Reprocessing Problem 1530 1530
Obstruction of Flow 1090 1090
Contamination 807 807
Erratic or Intermittent Display 755 755
Detachment of Device or Device Component 645 645
No Display/Image 629 629
Optical Obstruction 559 559
Device Contamination with Chemical or Other Material 454 454
Contamination /Decontamination Problem 439 439
Adverse Event Without Identified Device or Use Problem 415 415
Optical Distortion 335 335
Unintended Movement 178 178
Component Missing 131 131
Display or Visual Feedback Problem 89 89
Material Split, Cut or Torn 88 88
Loose or Intermittent Connection 78 78
Image Display Error/Artifact 76 76
Partial Blockage 66 66
Mechanical Problem 61 61
Leak/Splash 52 52
Collapse 50 50
Communication or Transmission Problem 41 41
Fracture 34 34
Failure to Disconnect 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
Device Damaged by Another Device 27 27
Suction Problem 27 27
Corroded 23 23
Device Handling Problem 23 23
Material Deformation 22 22
Loss of or Failure to Bond 22 22
Insufficient Information 19 19
Crack 16 16
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
Optical Discoloration 13 13
Failure to Disinfect 13 13
Mechanical Jam 13 13
Dent in Material 12 12
Insufficient Flow or Under Infusion 11 11
Gas/Air Leak 11 11
Device Contamination with Body Fluid 10 10
Material Separation 10 10
Separation Failure 9 9
Defective Component 9 9
Problem with Sterilization 8 8
Material Twisted/Bent 8 8
Degraded 8 8
Appropriate Term/Code Not Available 8 8
Material Protrusion/Extrusion 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
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
Failure to Align 5 5
Material Perforation 5 5
Pressure Problem 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
Difficult to Remove 4 4
Device-Device Incompatibility 4 4
Reflux within Device 4 4
Defective Device 4 4
Noise, Audible 4 4
Restricted Flow rate 4 4
Disconnection 3 3
Difficult to Insert 3 3
Flaked 3 3
Entrapment of Device 3 3
Misfocusing 3 3
Naturally Worn 3 3
Output Problem 3 3
Material Fragmentation 3 3
Display Difficult to Read 3 3
Material Discolored 3 3
Difficult to Open or Close 3 3

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 1397 1397
No Consequences Or Impact To Patient 445 445
Hemorrhage/Bleeding 165 165
Perforation 158 158
Insufficient Information 157 157
Foreign Body In Patient 88 88
No Patient Involvement 85 85
Unspecified Infection 38 38
Injury 37 37
Bacterial Infection 37 37
Drug Resistant Bacterial Infection 27 27
Fever 24 24
Unspecified Hepatic or Biliary Problem 17 17
Pain 16 16
Pancreatitis 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Unspecified Tissue Injury 15 15
Abdominal Pain 14 14
Laceration(s) 14 14
Stenosis 14 14
Sepsis 12 12
Abrasion 10 10
Peritonitis 10 10
Chest Pain 10 10
Abscess 10 10
Unspecified Gastrointestinal Problem 9 9
Bowel Perforation 9 9
Gastrointestinal Hemorrhage 9 9
Chemical Exposure 8 8
Malaise 7 7
Chills 7 7
Laceration(s) of Esophagus 7 7
Pneumonia 7 7
Pneumothorax 6 6
Nausea 6 6
Muscle/Tendon Damage 6 6
Internal Organ Perforation 5 5
Death 5 5
No Code Available 5 5
Swelling/ Edema 5 5
Respiratory Tract Infection 4 4
Viral Infection 4 4
Hematoma 4 4
Fistula 4 4
Vomiting 4 4
Thrombosis/Thrombus 4 4
Burn(s) 4 4
Therapeutic Effects, Unexpected 4 4
Unspecified Respiratory Problem 4 4
Perforation of Esophagus 4 4
Ulcer 3 3
Exposure to Body Fluids 3 3
Pleural Effusion 3 3
Multiple Organ Failure 3 3
Pulmonary Embolism 3 3
Shock 3 3
Hematemesis 3 3
Blood Loss 3 3
Aspiration Pneumonitis 3 3
Liver Failure 3 3
Patient Problem/Medical Problem 3 3
Hyperbilirubinemia 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
Hyperemia 2 2
Aspiration/Inhalation 2 2
Eye Injury 2 2
Vascular Dissection 2 2
Unspecified Eye / Vision Problem 1 1
Genital Bleeding 1 1
Hypovolemic Shock 1 1
Anemia 1 1
Cough 1 1
Coma 1 1
Ascites 1 1
Tachycardia 1 1
Sore Throat 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Mediastinal Shift 1 1
Inflammation 1 1
Embolism/Embolus 1 1
Swelling 1 1
Septic Shock 1 1
Organ Dehiscence 1 1
Tissue Damage 1 1
Bradycardia 1 1
Cellulitis 1 1
Stenosis of the esophagus 1 1
Itching Sensation 1 1
Headache 1 1
Embolism 1 1
Pyrosis/Heartburn 1 1
Unspecified Mental, Emotional or Behavioural Problem 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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