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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
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 4373 4373

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 5857 5857
Break 4472 4472
Microbial Contamination of Device 2338 2338
No Display/Image 1956 1956
Fluid/Blood Leak 1676 1676
Erratic or Intermittent Display 1480 1480
Obstruction of Flow 1461 1461
Device Reprocessing Problem 1427 1427
Optical Obstruction 1419 1419
Communication or Transmission Problem 1175 1175
Detachment of Device or Device Component 980 980
Optical Distortion 748 748
Contamination 714 714
Unintended Movement 421 421
Poor Quality Image 390 390
Display or Visual Feedback Problem 369 369
Contamination /Decontamination Problem 332 332
Adverse Event Without Identified Device or Use Problem 332 332
Device Contamination with Chemical or Other Material 294 294
Material Split, Cut or Torn 163 163
Loose or Intermittent Connection 137 137
Component Missing 129 129
Mechanical Problem 92 92
Electrical /Electronic Property Problem 86 86
Image Display Error/Artifact 80 80
Output Problem 77 77
Partial Blockage 66 66
Fracture 65 65
Optical Problem 64 64
Leak/Splash 57 57
Crack 54 54
Material Puncture/Hole 50 50
Physical Resistance/Sticking 48 48
Connection Problem 46 46
Failure to Power Up 43 43
Complete Blockage 39 39
Incomplete or Inadequate Connection 36 36
Burst Container or Vessel 35 35
Moisture Damage 33 33
Material Deformation 33 33
Collapse 32 32
Corroded 29 29
Suction Problem 27 27
Defective Component 24 24
Optical Discoloration 24 24
Improper or Incorrect Procedure or Method 23 23
Blocked Connection 22 22
Deformation Due to Compressive Stress 22 22
Degraded 22 22
Intermittent Continuity 21 21
Failure to Disconnect 21 21
Use of Device Problem 21 21
Material Perforation 19 19
Defective Device 19 19
Device Damaged by Another Device 19 19
Mechanical Jam 19 19
Device Handling Problem 19 19
Scratched Material 18 18
Appropriate Term/Code Not Available 18 18
Material Integrity Problem 16 16
Power Problem 15 15
Residue After Decontamination 15 15
Material Too Rigid or Stiff 14 14
Moisture or Humidity Problem 14 14
Material Protrusion/Extrusion 13 13
Insufficient Information 13 13
Material Fragmentation 13 13
Restricted Flow rate 13 13
Loss of or Failure to Bond 12 12
Failure to Eject 12 12
Key or Button Unresponsive/not Working 12 12
Material Twisted/Bent 11 11
Material Separation 11 11
Device Contamination with Body Fluid 11 11
Dent in Material 11 11
Free or Unrestricted Flow 11 11
Gas/Air Leak 10 10
Separation Failure 10 10
Stretched 9 9
Failure to Disinfect 9 9
Circuit Failure 8 8
Particulates 8 8
Sharp Edges 8 8
Device Fell 7 7
Unintended Electrical Shock 7 7
Naturally Worn 7 7
No Flow 7 7
Unintended System Motion 7 7
Backflow 7 7
Component Incompatible 6 6
Peeled/Delaminated 6 6
Inflation Problem 6 6
Flaked 6 6
Disconnection 6 6
Increase in Pressure 6 6
Electrical Power Problem 6 6
No Apparent Adverse Event 6 6
Positioning Problem 5 5
Electrical Shorting 5 5
Device Contaminated at the User Facility 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 26376 26376
No Consequences Or Impact To Patient 491 491
No Known Impact Or Consequence To Patient 447 447
Insufficient Information 239 239
Hemorrhage/Bleeding 150 150
No Patient Involvement 97 97
Perforation 92 92
Bowel Perforation 62 62
Laceration(s) 34 34
Pain 23 23
Injury 21 21
Foreign Body In Patient 20 20
Unspecified Infection 20 20
Abdominal Pain 19 19
Abrasion 14 14
Bacterial Infection 14 14
Tissue Damage 14 14
Internal Organ Perforation 10 10
Electric Shock 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
No Code Available 9 9
Unspecified Tissue Injury 9 9
Unspecified Gastrointestinal Problem 7 7
Chemical Exposure 7 7
Hematoma 7 7
Death 6 6
Blood Loss 6 6
Device Embedded In Tissue or Plaque 6 6
Tachycardia 5 5
Unspecified Hepatic or Biliary Problem 5 5
Drug Resistant Bacterial Infection 4 4
Pancreatitis 4 4
Viral Infection 4 4
Discomfort 4 4
Fever 4 4
Bruise/Contusion 4 4
Burn(s) 4 4
Erosion 4 4
Low Blood Pressure/ Hypotension 4 4
Inflammation 4 4
Hypoxia 3 3
Hepatitis 3 3
Ulcer 3 3
Abdominal Distention 3 3
Peritonitis 3 3
Rupture 3 3
Pneumonia 3 3
Gastrointestinal Hemorrhage 3 3
Constipation 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Swelling/ Edema 2 2
Septic Shock 2 2
Burning Sensation 2 2
Chills 2 2
No Information 2 2
Increased Respiratory Rate 2 2
Shaking/Tremors 2 2
Hyperemia 2 2
High Blood Pressure/ Hypertension 2 2
Hypovolemic Shock 2 2
Chest Pain 2 2
Undesired Nerve Stimulation 2 2
Exposure to Body Fluids 2 2
Abscess 2 2
Air Embolism 2 2
Bowel Burn 2 2
Cardiac Arrest 1 1
Headache 1 1
Diarrhea 1 1
Bradycardia 1 1
Oversedation 1 1
Muscle Weakness 1 1
Nausea 1 1
Sleep Dysfunction 1 1
Caustic/Chemical Burns 1 1
Lethargy 1 1
Patient Problem/Medical Problem 1 1
Skin Erosion 1 1
Sepsis 1 1
Excessive Tear Production 1 1
Stenosis 1 1
Malaise 1 1
Skin Inflammation 1 1
Low Oxygen Saturation 1 1
Transmissible Spongiform Encephalopathy(TSE) 1 1
Vitamin Deficiency 1 1
Skin Inflammation/ Irritation 1 1
Unspecified Eye / Vision Problem 1 1
Syncope/Fainting 1 1
Intra-Abdominal Hemorrhage 1 1
Melena 1 1
Stomach Ulceration 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 Medrobotics Corporation II Apr-17-2019
4 Olympus Corporation of the Americas II Feb-29-2024
5 Olympus Corporation of the Americas II Nov-09-2023
6 Olympus Corporation of the Americas II Jun-21-2022
7 Olympus Corporation of the Americas II Nov-27-2020
8 Pentax of America Inc II Sep-10-2021
9 Pentax of America Inc II Feb-19-2020
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