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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 2
AMBU A/S
  SUBSTANTIALLY EQUIVALENT 1
BPENDO, LLC
  SUBSTANTIALLY EQUIVALENT 1
ERA ENDOSCOPY S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
GI VIEW LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU RED PINE MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU AGS MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LUMENDI, LLC
  SUBSTANTIALLY EQUIVALENT 3
MOTUS GI MEDICAL TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 4
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SANESO INC.
  SUBSTANTIALLY EQUIVALENT 1
SMART MEDICAL SYSTEMS LTD.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2019 417 417
2020 687 687
2021 2444 2444
2022 8345 8345
2023 11748 11748
2024 11643 11643

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 9039 9039
Break 4560 4560
Microbial Contamination of Device 2780 2780
No Display/Image 2517 2517
Erratic or Intermittent Display 2077 2077
Optical Obstruction 2012 2012
Fluid/Blood Leak 1942 1942
Obstruction of Flow 1802 1802
Device Reprocessing Problem 1676 1676
Communication or Transmission Problem 1625 1625
Detachment of Device or Device Component 1166 1166
Optical Distortion 756 756
Contamination 728 728
Unintended Movement 445 445
Poor Quality Image 407 407
Display or Visual Feedback Problem 375 375
Adverse Event Without Identified Device or Use Problem 351 351
Contamination /Decontamination Problem 340 340
Device Contamination with Chemical or Other Material 295 295
Material Split, Cut or Torn 195 195
Thermal Decomposition of Device 169 169
Loose or Intermittent Connection 160 160
Component Missing 130 130
Mechanical Problem 105 105
Electrical /Electronic Property Problem 88 88
Image Display Error/Artifact 88 88
Output Problem 85 85
Partial Blockage 76 76
Crack 69 69
Fracture 68 68
Optical Problem 67 67
Leak/Splash 67 67
Physical Resistance/Sticking 56 56
Failure to Power Up 55 55
Complete Blockage 51 51
Material Puncture/Hole 50 50
Connection Problem 49 49
Incomplete or Inadequate Connection 38 38
Material Deformation 38 38
Burst Container or Vessel 37 37
Corroded 36 36
Moisture Damage 34 34
Collapse 32 32
Defective Component 31 31
Suction Problem 30 30
Degraded 29 29
Melted 26 26
Improper or Incorrect Procedure or Method 26 26
Optical Discoloration 25 25
Deformation Due to Compressive Stress 23 23

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 33586 33586
No Consequences Or Impact To Patient 491 491
No Known Impact Or Consequence To Patient 447 447
Insufficient Information 245 245
Hemorrhage/Bleeding 163 163
Perforation 99 99
No Patient Involvement 97 97
Bowel Perforation 76 76
Laceration(s) 37 37
Pain 24 24
Abdominal Pain 22 22
Foreign Body In Patient 22 22
Unspecified Infection 21 21
Injury 21 21
Bacterial Infection 16 16
Tissue Damage 14 14
Abrasion 14 14
Internal Organ Perforation 12 12
Unspecified Tissue Injury 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Unspecified Gastrointestinal Problem 10 10
Electric Shock 9 9
No Code Available 9 9
Pancreatitis 7 7
Septic Shock 7 7
Hematoma 7 7
Chemical Exposure 7 7
Device Embedded In Tissue or Plaque 6 6
Bruise/Contusion 6 6
Death 6 6
Unspecified Hepatic or Biliary Problem 6 6
Discomfort 6 6
Blood Loss 6 6
Granuloma 5 5
Low Blood Pressure/ Hypotension 5 5
Tachycardia 5 5
Fever 5 5
Erosion 4 4
Burn(s) 4 4
Drug Resistant Bacterial Infection 4 4
Inflammation 4 4
Pneumonia 4 4
Viral Infection 4 4
Rupture 3 3
Peritonitis 3 3
Abdominal Distention 3 3
Hypoxia 3 3
Ulcer 3 3
Intra-Abdominal Hemorrhage 3 3
Hepatitis 3 3

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 Medrobotics Corporation II Apr-17-2019
4 Olympus Corporation of the Americas II Oct-11-2024
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 of America Inc II Sep-10-2021
10 Pentax of America Inc II Feb-19-2020
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