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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 5
BPENDO, LLC
  SUBSTANTIALLY EQUIVALENT 1
EASYGLIDE LTD.
  SUBSTANTIALLY EQUIVALENT 2
ENDOCHOICE, INC.
  SUBSTANTIALLY EQUIVALENT 2
ERA ENDOSCOPY S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 5
FUJINON, INC.
  SUBSTANTIALLY EQUIVALENT 2
GCE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
GI VIEW LTD.
  SUBSTANTIALLY EQUIVALENT 3
GUANGZHOU RED PINE MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU AGS MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INVENDO MEDICAL GBMH
  SUBSTANTIALLY EQUIVALENT 2
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 3
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
PEERMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PEERMEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
PENTAX MEDICAL COMPANY
  SUBSTANTIALLY EQUIVALENT 2
PENTAX MEDICAL OF AMERICA, INC
  SUBSTANTIALLY EQUIVALENT 1
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SANESO INC.
  SUBSTANTIALLY EQUIVALENT 1
SHEATHING TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMART MEDICAL SYSTEMS LTD.
  SUBSTANTIALLY EQUIVALENT 3
SMART MEDICAL SYSTEMS, LTD.
  SUBSTANTIALLY EQUIVALENT 2
UNITED STATES ENDOSCOPY GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 60 60
2015 99 99
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 5505 5505

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 6347 6347
Break 4503 4503
Microbial Contamination of Device 2845 2845
No Display/Image 2201 2201
Fluid/Blood Leak 1762 1762
Erratic or Intermittent Display 1598 1598
Obstruction of Flow 1523 1523
Optical Obstruction 1519 1519
Device Reprocessing Problem 1514 1514
Communication or Transmission Problem 1240 1240
Detachment of Device or Device Component 1011 1011
Optical Distortion 748 748
Contamination 715 715
Adverse Event Without Identified Device or Use Problem 445 445
Unintended Movement 422 422
Poor Quality Image 395 395
Display or Visual Feedback Problem 373 373
Contamination /Decontamination Problem 338 338
Device Contamination with Chemical or Other Material 310 310
Material Split, Cut or Torn 175 175
Loose or Intermittent Connection 142 142
Component Missing 129 129
Mechanical Problem 124 124
Electrical /Electronic Property Problem 89 89
Image Display Error/Artifact 83 83
Output Problem 77 77
Partial Blockage 71 71
Leak/Splash 67 67
Fracture 65 65
Optical Problem 64 64
Crack 56 56
Material Puncture/Hole 56 56
Physical Resistance/Sticking 49 49
Insufficient Information 48 48
Connection Problem 48 48
Failure to Power Up 46 46
Complete Blockage 44 44
Material Deformation 40 40
Burst Container or Vessel 39 39
Incomplete or Inadequate Connection 37 37
Appropriate Term/Code Not Available 36 36
Moisture Damage 34 34
Collapse 32 32
Corroded 32 32
Suction Problem 29 29
Degraded 28 28
Improper or Incorrect Procedure or Method 27 27
Use of Device Problem 26 26
Material Too Rigid or Stiff 26 26
Deformation Due to Compressive Stress 25 25
Optical Discoloration 24 24
Defective Component 24 24
Material Perforation 23 23
Device Handling Problem 23 23
Mechanical Jam 22 22
Blocked Connection 22 22
Material Protrusion/Extrusion 21 21
Failure to Disconnect 21 21
Intermittent Continuity 21 21
Defective Device 20 20
Scratched Material 20 20
Device Damaged by Another Device 19 19
Material Integrity Problem 18 18
Moisture or Humidity Problem 15 15
Power Problem 15 15
Residue After Decontamination 15 15
Loss of or Failure to Bond 13 13
Material Fragmentation 13 13
Restricted Flow rate 13 13
Device Operates Differently Than Expected 13 13
Free or Unrestricted Flow 12 12
Material Twisted/Bent 12 12
Failure to Eject 12 12
Key or Button Unresponsive/not Working 12 12
Dent in Material 12 12
Material Separation 12 12
Device Contamination with Body Fluid 11 11
Separation Failure 10 10
Failure to Disinfect 10 10
Gas/Air Leak 10 10
Detachment Of Device Component 9 9
Stretched 9 9
Particulates 8 8
Peeled/Delaminated 8 8
Device Issue 8 8
Circuit Failure 8 8
Naturally Worn 8 8
No Flow 8 8
Positioning Problem 8 8
Sharp Edges 8 8
Device Fell 7 7
Unintended Electrical Shock 7 7
No Apparent Adverse Event 7 7
Electrical Power Problem 7 7
Disconnection 7 7
Backflow 7 7
Flaked 7 7
Inflation Problem 7 7
Unintended System Motion 7 7
Increase in Pressure 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 27506 27506
No Known Impact Or Consequence To Patient 929 929
No Consequences Or Impact To Patient 805 805
Insufficient Information 241 241
Hemorrhage/Bleeding 156 157
Perforation 140 140
No Patient Involvement 134 134
Bowel Perforation 115 115
Unspecified Infection 46 46
Laceration(s) 44 45
Injury 43 43
Bacterial Infection 35 35
Blood Loss 34 34
Foreign Body In Patient 33 33
Pain 28 28
Abdominal Pain 27 28
Tissue Damage 22 22
Abrasion 21 21
Inflammation 21 21
No Information 21 21
Death 20 20
No Code Available 17 17
Electric Shock 13 13
Internal Organ Perforation 10 10
Chemical Exposure 9 9
Unspecified Tissue Injury 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Device Embedded In Tissue or Plaque 8 8
Patient Problem/Medical Problem 8 8
Excessive Tear Production 8 8
Discomfort 7 7
Hematoma 7 7
Fever 7 7
Skin Inflammation 7 7
Unspecified Gastrointestinal Problem 7 7
Unspecified Hepatic or Biliary Problem 5 5
Tachycardia 5 5
Burn(s) 5 5
Viral Infection 5 5
Erosion 4 4
Bruise/Contusion 4 4
Low Blood Pressure/ Hypotension 4 4
Drug Resistant Bacterial Infection 4 4
Pancreatitis 4 4
Gastrointestinal Hemorrhage 3 3
Abdominal Distention 3 3
Hypoxia 3 3
Hepatitis 3 3
Bowel Burn 3 3
Exposure to Body Fluids 3 3
Air Embolism 3 3
Peritonitis 3 3
Ulcer 3 3
Rupture 3 3
Burning Sensation 3 3
Pneumonia 3 3
Sepsis 2 2
Septic Shock 2 2
Undesired Nerve Stimulation 2 2
Chills 2 2
Increased Respiratory Rate 2 2
Shaking/Tremors 2 2
Chest Pain 2 2
Fistula 2 2
Diarrhea 2 2
Abscess 2 2
Bradycardia 2 2
Hyperemia 2 2
High Blood Pressure/ Hypertension 2 2
Hypovolemic Shock 2 2
Nausea 2 3
Constipation 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Swelling/ Edema 2 2
Transmissible Spongiform Encephalopathy(TSE) 1 1
Vitamin Deficiency 1 1
Skin Inflammation/ Irritation 1 1
Unspecified Eye / Vision Problem 1 1
Not Applicable 1 1
Intra-Abdominal Hemorrhage 1 1
Melena 1 1
Stomach Ulceration 1 1
Syncope/Fainting 1 1
Intermenstrual Bleeding 1 1
Low Oxygen Saturation 1 1
Decreased Respiratory Rate 1 1
Lethargy 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
Cardiopulmonary Arrest 1 1
Sleep Dysfunction 1 1
Burn, Thermal 1 1
Abdominal Cramps 1 1
Caustic/Chemical Burns 1 1
Malaise 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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