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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device colonoscope and accessories, flexible/rigid
Definition To examine or perform procedures in the colon or rectum 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 CodeFDF
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
ACTUATED MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMBU A/S
  SUBSTANTIALLY EQUIVALENT 1
AVANTIS MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BPENDO, LLC
  SUBSTANTIALLY EQUIVALENT 1
ERA ENDOSCOPY S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 2
GCE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
GI VIEW LTD.
  SUBSTANTIALLY EQUIVALENT 2
GUANGZHOU RED PINE MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU AGS MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INVENDO MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 2
LUMENDI, LLC
  SUBSTANTIALLY EQUIVALENT 6
MEDROBOTICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
MOTUS GI MEDICAL TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 7
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
PENTAX MEDICAL OF AMERICA, INC
  SUBSTANTIALLY EQUIVALENT 1
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SANESO INC.
  SUBSTANTIALLY EQUIVALENT 1
SMART MEDICAL SYSTEMS LTD.
  SUBSTANTIALLY EQUIVALENT 3
UNITED STATES ENDOSCOPY GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 170 170
2017 369 369
2018 388 388
2019 417 417
2020 687 687
2021 2444 2444
2022 8345 8345
2023 11748 11748
2024 3353 3353

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 5322 5322
Break 4477 4477
Microbial Contamination of Device 2672 2672
No Display/Image 2021 2021
Fluid/Blood Leak 1660 1660
Device Reprocessing Problem 1435 1435
Obstruction of Flow 1435 1435
Erratic or Intermittent Display 1427 1427
Optical Obstruction 1375 1375
Communication or Transmission Problem 1101 1101
Detachment of Device or Device Component 965 965
Optical Distortion 748 748
Contamination 712 712
Unintended Movement 420 420
Adverse Event Without Identified Device or Use Problem 403 403
Poor Quality Image 389 389
Display or Visual Feedback Problem 368 368
Contamination /Decontamination Problem 338 338
Device Contamination with Chemical or Other Material 306 306
Material Split, Cut or Torn 160 160
Loose or Intermittent Connection 138 138
Component Missing 129 129
Mechanical Problem 120 120
Electrical /Electronic Property Problem 85 85
Image Display Error/Artifact 79 79
Output Problem 76 76
Partial Blockage 69 69
Fracture 65 65
Optical Problem 64 64
Leak/Splash 63 63
Material Puncture/Hole 55 55
Crack 54 54
Physical Resistance/Sticking 48 48
Connection Problem 46 46
Failure to Power Up 41 41
Complete Blockage 40 40
Burst Container or Vessel 39 39
Material Deformation 39 39
Insufficient Information 36 36
Appropriate Term/Code Not Available 36 36
Incomplete or Inadequate Connection 36 36
Moisture Damage 34 34
Collapse 32 32
Corroded 30 30
Suction Problem 29 29
Degraded 27 27
Improper or Incorrect Procedure or Method 26 26
Use of Device Problem 26 26
Material Too Rigid or Stiff 25 25
Optical Discoloration 24 24
Deformation Due to Compressive Stress 23 23
Blocked Connection 22 22
Device Handling Problem 22 22
Material Perforation 22 22
Defective Component 22 22
Failure to Disconnect 21 21
Intermittent Continuity 21 21
Scratched Material 20 20
Material Protrusion/Extrusion 20 20
Mechanical Jam 20 20
Device Damaged by Another Device 19 19
Defective Device 18 18
Material Integrity Problem 16 16
Moisture or Humidity Problem 15 15
Power Problem 15 15
Residue After Decontamination 15 15
Restricted Flow rate 13 13
Material Fragmentation 12 12
Loss of or Failure to Bond 12 12
Dent in Material 12 12
Material Twisted/Bent 12 12
Failure to Eject 12 12
Key or Button Unresponsive/not Working 12 12
Free or Unrestricted Flow 11 11
Device Contamination with Body Fluid 11 11
Separation Failure 10 10
Material Separation 10 10
Failure to Disinfect 10 10
Device Operates Differently Than Expected 10 10
Stretched 9 9
Particulates 8 8
Detachment Of Device Component 8 8
Circuit Failure 8 8
Naturally Worn 8 8
Sharp Edges 8 8
Device Fell 7 7
Unintended Electrical Shock 7 7
No Apparent Adverse Event 7 7
No Flow 7 7
Gas/Air Leak 7 7
Disconnection 7 7
Backflow 7 7
Flaked 7 7
Peeled/Delaminated 7 7
Unintended System Motion 7 7
Increase in Pressure 7 7
Device Issue 7 7
Inflation Problem 6 6
Component Incompatible 6 6
Electrical Power Problem 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 25364 25364
No Known Impact Or Consequence To Patient 914 914
No Consequences Or Impact To Patient 734 734
Insufficient Information 239 239
Hemorrhage/Bleeding 149 150
No Patient Involvement 134 134
Perforation 130 130
Bowel Perforation 93 93
Laceration(s) 44 45
Unspecified Infection 39 39
Injury 35 35
Blood Loss 34 34
Foreign Body In Patient 30 30
Bacterial Infection 27 27
Pain 26 26
Abdominal Pain 23 24
Inflammation 21 21
Tissue Damage 20 20
Abrasion 19 19
No Information 19 19
Death 17 17
No Code Available 15 15
Internal Organ Perforation 10 10
Electric Shock 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Unspecified Tissue Injury 9 9
Chemical Exposure 8 8
Patient Problem/Medical Problem 8 8
Device Embedded In Tissue or Plaque 8 8
Hematoma 7 7
Skin Inflammation 7 7
Discomfort 5 5
Excessive Tear Production 5 5
Fever 5 5
Tachycardia 5 5
Unspecified Hepatic or Biliary Problem 5 5
Pancreatitis 4 4
Drug Resistant Bacterial Infection 4 4
Unspecified Gastrointestinal Problem 4 4
Burn(s) 4 4
Erosion 4 4
Bruise/Contusion 4 4
Low Blood Pressure/ Hypotension 4 4
Viral Infection 4 4
Peritonitis 3 3
Ulcer 3 3
Rupture 3 3
Pneumonia 3 3
Hypoxia 3 3
Hepatitis 3 3
Bowel Burn 3 3
Air Embolism 3 3
Gastrointestinal Hemorrhage 3 3
Unspecified Mental, Emotional or Behavioural Problem 2 2
Swelling/ Edema 2 2
Abdominal Distention 2 2
Constipation 2 2
Chest Pain 2 2
Fistula 2 2
Diarrhea 2 2
Bradycardia 2 2
Abscess 2 2
Exposure to Body Fluids 2 2
Hyperemia 2 2
High Blood Pressure/ Hypertension 2 2
Hypovolemic Shock 2 2
Nausea 2 3
Undesired Nerve Stimulation 2 2
Septic Shock 2 2
Chills 2 2
Increased Respiratory Rate 2 2
Shaking/Tremors 2 2
Sleep Dysfunction 1 1
Abdominal Cramps 1 1
Caustic/Chemical Burns 1 1
Toxicity 1 1
Low Oxygen Saturation 1 1
Decreased Respiratory Rate 1 1
Distress 1 1
Stenosis 1 1
Malaise 1 1
Inadequate Pain Relief 1 1
Neck Pain 1 1
Cramp(s) 1 1
Dizziness 1 2
HIV, Human Immunodeficiency Virus 1 1
Myalgia 1 1
Skin Erosion 1 1
Vomiting 1 1
Burning Sensation 1 1
Sepsis 1 1
Nerve Damage 1 1
Oversedation 1 1
Muscle Spasm(s) 1 1
Muscle Weakness 1 1
Dyspnea 1 2
Headache 1 1
Cardiac Arrest 1 1
Syncope/Fainting 1 1
Not Applicable 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aizu Olympus Co., Ltd. II Nov-29-2023
2 Aizu Olympus Co., Ltd. II Nov-17-2023
3 EndoChoice, Inc. II Jan-27-2016
4 Medrobotics Corporation II Apr-17-2019
5 Olympus Corporation of the Americas II Feb-29-2024
6 Olympus Corporation of the Americas II Nov-09-2023
7 Olympus Corporation of the Americas II Jun-21-2022
8 Olympus Corporation of the Americas II Nov-27-2020
9 Pentax Medical Company II Jul-23-2016
10 Pentax Medical Company II Jun-28-2016
11 Pentax of America Inc II Sep-10-2021
12 Pentax of America Inc II Feb-19-2020
13 Pentax of America Inc II Nov-19-2016
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