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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 3353 3353

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 5322 5322
Break 4481 4481
Microbial Contamination of Device 2685 2685
No Display/Image 2074 2074
Fluid/Blood Leak 1660 1660
Device Reprocessing Problem 1442 1442
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
Adverse Event Without Identified Device or Use Problem 437 437
Unintended Movement 420 420
Poor Quality Image 390 390
Display or Visual Feedback Problem 370 370
Contamination /Decontamination Problem 338 338
Device Contamination with Chemical or Other Material 309 309
Material Split, Cut or Torn 160 160
Loose or Intermittent Connection 138 138
Component Missing 129 129
Mechanical Problem 121 121
Electrical /Electronic Property Problem 88 88
Image Display Error/Artifact 80 80
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
Insufficient Information 48 48
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
Appropriate Term/Code Not Available 36 36
Incomplete or Inadequate Connection 36 36
Moisture Damage 34 34
Collapse 32 32
Corroded 31 31
Suction Problem 29 29
Improper or Incorrect Procedure or Method 27 27
Degraded 27 27
Use of Device Problem 26 26
Material Too Rigid or Stiff 26 26
Optical Discoloration 24 24
Deformation Due to Compressive Stress 24 24
Device Handling Problem 23 23
Blocked Connection 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 17 17
Moisture or Humidity Problem 15 15
Power Problem 15 15
Residue After Decontamination 15 15
Loss of or Failure to Bond 13 13
Restricted Flow rate 13 13
Device Operates Differently Than Expected 13 13
Material Twisted/Bent 12 12
Failure to Eject 12 12
Key or Button Unresponsive/not Working 12 12
Material Fragmentation 12 12
Dent in Material 12 12
Device Contamination with Body Fluid 11 11
Free or Unrestricted Flow 11 11
Separation Failure 10 10
Material Separation 10 10
Failure to Disinfect 10 10
Detachment Of Device Component 9 9
Stretched 9 9
Particulates 8 8
Device Issue 8 8
Circuit Failure 8 8
Naturally Worn 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
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
Difficult to Remove 6 6
Inflation 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 929 929
No Consequences Or Impact To Patient 805 805
Insufficient Information 241 241
Hemorrhage/Bleeding 150 151
Perforation 137 137
No Patient Involvement 134 134
Bowel Perforation 112 112
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 27 27
Abdominal Pain 26 27
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
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Unspecified Tissue Injury 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
Tachycardia 5 5
Unspecified Hepatic or Biliary Problem 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
Unspecified Gastrointestinal Problem 4 4
Gastrointestinal Hemorrhage 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
Pneumonia 3 3
Sepsis 2 2
Septic Shock 2 2
Undesired Nerve Stimulation 2 2
Burning Sensation 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
Unspecified Mental, Emotional or Behavioural Problem 2 2
Swelling/ Edema 2 2
Abdominal Distention 2 2
Constipation 2 2
Syncope/Fainting 1 1
Intermenstrual Bleeding 1 1
Low Oxygen Saturation 1 1
Decreased Respiratory Rate 1 1
Lethargy 1 1
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
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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