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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
Regulation Description Endoscope and accessories.
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
ALTON (SHANGHAI) MEDICAL INSTRUMENTS CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
AMBU A/S
  SUBSTANTIALLY EQUIVALENT 2
EVOENDO INC
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
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 CORP.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PENTAX OF AMERICA, INC
  SUBSTANTIALLY EQUIVALENT 1
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 601 601
2021 1755 1755
2022 6216 6216
2023 9874 9874
2024 9258 9258
2025 4046 4046

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 11029 11029
Device Reprocessing Problem 2485 2485
Break 2395 2395
Poor Quality Image 2392 2392
Fluid/Blood Leak 1899 1899
Microbial Contamination of Device 1890 1890
Obstruction of Flow 1558 1558
Erratic or Intermittent Display 1218 1218
No Display/Image 1023 1023
Optical Obstruction 948 948
Contamination 897 897
Detachment of Device or Device Component 870 870
Contamination /Decontamination Problem 482 482
Device Contamination with Chemical or Other Material 475 475
Adverse Event Without Identified Device or Use Problem 455 455
Thermal Decomposition of Device 439 439
Residue After Decontamination 370 370
Optical Distortion 342 342
Unintended Movement 192 192
Melted 137 137
Material Split, Cut or Torn 132 132
Component Missing 131 131
Loose or Intermittent Connection 114 114
Display or Visual Feedback Problem 107 107
Image Display Error/Artifact 95 95
Misfocusing 85 85
Material Deformation 81 81
Partial Blockage 80 80
Mechanical Problem 75 75
Flare or Flash 62 62
Leak/Splash 62 62
Communication or Transmission Problem 58 58
Collapse 57 57
Improper Flow or Infusion 53 53
Corroded 50 50
Crack 48 48
Peeled/Delaminated 47 47
Physical Resistance/Sticking 46 46
Optical Problem 46 46
Complete Blockage 45 45
Gas/Air Leak 45 45
Degraded 43 43
Overheating of Device 43 43
Scratched Material 40 40
Improper or Incorrect Procedure or Method 37 37
Material Too Rigid or Stiff 37 37
Material Integrity Problem 36 36
Fracture 36 36
Failure to Disconnect 34 34
Electrical /Electronic Property Problem 34 34

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 30344 30344
No Consequences Or Impact To Patient 381 381
Hemorrhage/Bleeding 222 222
Insufficient Information 187 187
Perforation 161 161
No Known Impact Or Consequence To Patient 160 160
Foreign Body In Patient 97 97
No Patient Involvement 77 77
Bacterial Infection 57 57
Fever 38 38
Unspecified Infection 34 34
Drug Resistant Bacterial Infection 28 28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
Unspecified Tissue Injury 21 21
Pain 20 20
Injury 19 19
Abdominal Pain 18 18
Pancreatitis 18 18
Unspecified Hepatic or Biliary Problem 17 17
Chest Pain 15 15
Peritonitis 14 14
Stenosis 14 14
Bowel Perforation 14 14
Laceration(s) 13 13
Sepsis 12 12
Pneumothorax 12 12
Gastrointestinal Hemorrhage 11 11
Unspecified Gastrointestinal Problem 10 10
Abscess 10 10
Pleural Effusion 8 8
Perforation of Esophagus 7 7
Laceration(s) of Esophagus 7 7
Malaise 7 7
Stenosis of the esophagus 7 7
Pneumonia 7 7
Chills 7 7
Fistula 6 6
Nausea 6 6
Muscle/Tendon Damage 6 6
Swelling/ Edema 6 6
Abrasion 6 6
Pulmonary Emphysema 5 5
Aspiration Pneumonitis 5 5
Unspecified Respiratory Problem 5 5
Internal Organ Perforation 5 5
Chemical Exposure 4 4
No Code Available 4 4
Respiratory Tract Infection 4 4
Fungal Infection 4 4
Thrombosis/Thrombus 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Aomori Olympus Co., Ltd. II Sep-07-2023
2 Olympus Corporation of the Americas II Dec-05-2024
3 Olympus Corporation of the Americas II Nov-20-2024
4 Olympus Corporation of the Americas II Jun-21-2022
5 Olympus Corporation of the Americas II Nov-27-2020
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