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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 11
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 2
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 9874 9874
2024 6555 6555

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 9458 9458
Break 2324 2324
Microbial Contamination of Device 2234 2234
Poor Quality Image 2038 2038
Fluid/Blood Leak 1795 1795
Device Reprocessing Problem 1782 1782
Obstruction of Flow 1272 1272
Erratic or Intermittent Display 970 970
Contamination 813 813
No Display/Image 802 802
Optical Obstruction 733 733
Detachment of Device or Device Component 714 714
Adverse Event Without Identified Device or Use Problem 509 509
Device Contamination with Chemical or Other Material 470 470
Contamination /Decontamination Problem 451 451
Optical Distortion 337 337
Unintended Movement 180 180
Component Missing 131 131
Material Split, Cut or Torn 97 97
Display or Visual Feedback Problem 90 90
Loose or Intermittent Connection 88 88
Image Display Error/Artifact 82 82
Partial Blockage 73 73
Mechanical Problem 66 66
Leak/Splash 62 62
Collapse 50 50
Communication or Transmission Problem 43 43
Improper or Incorrect Procedure or Method 39 39
Material Too Rigid or Stiff 35 35
Fracture 34 34
Failure to Disconnect 34 34
Physical Resistance/Sticking 33 33
Peeled/Delaminated 33 33
Insufficient Information 32 32
Optical Problem 31 31
Complete Blockage 30 30
Device Handling Problem 29 29
Suction Problem 29 29
Device Damaged by Another Device 27 27
Material Deformation 25 25
Corroded 24 24
Deformation Due to Compressive Stress 23 23
Loss of or Failure to Bond 22 22
Crack 21 21
Appropriate Term/Code Not Available 21 21
Use of Device Problem 21 21
Mechanical Jam 20 20
Scratched Material 18 18
Moisture Damage 16 16
Electrical /Electronic Property Problem 15 15

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 23681 23681
No Known Impact Or Consequence To Patient 1766 1766
No Consequences Or Impact To Patient 558 558
Hemorrhage/Bleeding 201 201
Perforation 177 177
Insufficient Information 157 157
No Patient Involvement 134 134
Foreign Body In Patient 109 109
Bacterial Infection 75 75
Unspecified Infection 44 44
Injury 44 44
Fever 37 37
Drug Resistant Bacterial Infection 27 27
Unspecified Tissue Injury 19 19
Abdominal Pain 18 18
Pain 18 18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 17 17
Unspecified Hepatic or Biliary Problem 17 17
Laceration(s) 17 17
Pancreatitis 17 17
No Code Available 17 17
Chest Pain 15 15
Stenosis 14 14
Peritonitis 14 14
Inflammation 14 14
No Information 13 13
Bowel Perforation 13 13
Sepsis 12 12
Abrasion 11 11
Abscess 10 10
Pneumothorax 10 10
Unspecified Gastrointestinal Problem 10 10
Gastrointestinal Hemorrhage 10 10
Chills 8 8
Chemical Exposure 8 8
Laceration(s) of Esophagus 8 8
Death 7 7
Perforation of Esophagus 7 7
Malaise 7 7
Burn(s) 7 7
Pneumonia 7 7
Fistula 6 6
Pleural Effusion 6 6
Stenosis of the esophagus 6 6
Muscle/Tendon Damage 6 6
Nausea 6 6
Vomiting 5 5
Exposure to Body Fluids 5 5
Swelling/ Edema 5 5
Unspecified Respiratory Problem 5 5

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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