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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 9
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
OLYMPUS MEDICAL SYSTEMS CORPORATION
  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 9874 9874
2024 8455 8455

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 10491 10491
Break 2328 2328
Poor Quality Image 2064 2064
Microbial Contamination of Device 1941 1941
Device Reprocessing Problem 1855 1855
Fluid/Blood Leak 1824 1824
Obstruction of Flow 1329 1329
Erratic or Intermittent Display 1051 1051
No Display/Image 852 852
Contamination 812 812
Optical Obstruction 809 809
Detachment of Device or Device Component 739 739
Adverse Event Without Identified Device or Use Problem 481 481
Device Contamination with Chemical or Other Material 457 457
Contamination /Decontamination Problem 446 446
Optical Distortion 337 337
Thermal Decomposition of Device 250 250
Unintended Movement 186 186
Component Missing 131 131
Material Split, Cut or Torn 102 102
Loose or Intermittent Connection 94 94
Display or Visual Feedback Problem 89 89
Image Display Error/Artifact 79 79
Partial Blockage 74 74
Mechanical Problem 66 66
Leak/Splash 57 57
Collapse 50 50
Communication or Transmission Problem 44 44
Peeled/Delaminated 36 36
Material Too Rigid or Stiff 36 36
Improper or Incorrect Procedure or Method 35 35
Physical Resistance/Sticking 34 34
Failure to Disconnect 34 34
Fracture 34 34
Complete Blockage 32 32
Optical Problem 31 31
Suction Problem 28 28
Deformation Due to Compressive Stress 27 27
Device Damaged by Another Device 27 27
Melted 26 26
Device Handling Problem 25 25
Corroded 24 24
Crack 23 23
Material Deformation 23 23
Insufficient Information 22 22
Loss of or Failure to Bond 22 22
Scratched Material 20 20
Overheating of Device 19 19
Use of Device Problem 19 19
Degraded 18 18

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 25561 25561
No Known Impact Or Consequence To Patient 1397 1397
No Consequences Or Impact To Patient 445 445
Hemorrhage/Bleeding 209 209
Perforation 173 173
Insufficient Information 157 157
Foreign Body In Patient 91 91
No Patient Involvement 85 85
Bacterial Infection 57 57
Unspecified Infection 42 42
Fever 37 37
Injury 37 37
Drug Resistant Bacterial Infection 27 27
Unspecified Tissue Injury 20 20
Abdominal Pain 19 19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Pain 18 18
Pancreatitis 18 18
Unspecified Hepatic or Biliary Problem 17 17
Chest Pain 15 15
Laceration(s) 15 15
Stenosis 14 14
Peritonitis 14 14
Sepsis 12 12
Bowel Perforation 11 11
Gastrointestinal Hemorrhage 10 10
Unspecified Gastrointestinal Problem 10 10
Pneumothorax 10 10
Abrasion 10 10
Abscess 10 10
Chemical Exposure 8 8
Stenosis of the esophagus 7 7
Chills 7 7
Malaise 7 7
Laceration(s) of Esophagus 7 7
Pneumonia 7 7
Nausea 6 6
Perforation of Esophagus 6 6
Swelling/ Edema 6 6
Fistula 6 6
Pleural Effusion 6 6
Muscle/Tendon Damage 6 6
No Code Available 5 5
Unspecified Respiratory Problem 5 5
Death 5 5
Internal Organ Perforation 5 5
Thrombosis/Thrombus 4 4
Burn(s) 4 4
Vomiting 4 4
Viral Infection 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Aomori Olympus Co., Ltd. II Sep-07-2023
2 Olympus Corporation of the Americas II Nov-20-2024
3 Olympus Corporation of the Americas II Jun-21-2022
4 Olympus Corporation of the Americas II Nov-27-2020
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