Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 3353 3353

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 5322 5322
Break 4457 4457
Microbial Contamination of Device 2227 2227
No Display/Image 1907 1907
Fluid/Blood Leak 1655 1655
Erratic or Intermittent Display 1427 1427
Obstruction of Flow 1427 1427
Device Reprocessing Problem 1388 1388
Optical Obstruction 1375 1375
Communication or Transmission Problem 1101 1101
Detachment of Device or Device Component 959 959
Optical Distortion 748 748
Contamination 711 711
Unintended Movement 420 420
Poor Quality Image 388 388
Display or Visual Feedback Problem 367 367
Contamination /Decontamination Problem 332 332
Adverse Event Without Identified Device or Use Problem 325 325
Device Contamination with Chemical or Other Material 293 293
Material Split, Cut or Torn 159 159
Loose or Intermittent Connection 137 137
Component Missing 129 129
Mechanical Problem 91 91
Electrical /Electronic Property Problem 85 85
Image Display Error/Artifact 78 78
Output Problem 76 76
Fracture 65 65
Partial Blockage 65 65
Optical Problem 64 64
Leak/Splash 55 55
Crack 53 53
Material Puncture/Hole 49 49
Physical Resistance/Sticking 47 47
Connection Problem 45 45
Failure to Power Up 41 41
Complete Blockage 39 39
Incomplete or Inadequate Connection 36 36
Burst Container or Vessel 35 35
Moisture Damage 33 33
Collapse 32 32
Material Deformation 32 32
Corroded 29 29
Suction Problem 27 27
Optical Discoloration 24 24
Improper or Incorrect Procedure or Method 23 23
Blocked Connection 22 22
Deformation Due to Compressive Stress 22 22
Defective Component 22 22
Failure to Disconnect 21 21
Use of Device Problem 21 21
Intermittent Continuity 21 21
Degraded 21 21
Material Perforation 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
Defective Device 18 18
Residue After Decontamination 15 15
Power Problem 15 15
Material Integrity Problem 15 15
Moisture or Humidity Problem 14 14
Material Too Rigid or Stiff 14 14
Restricted Flow rate 13 13
Insufficient Information 13 13
Key or Button Unresponsive/not Working 12 12
Failure to Eject 12 12
Material Protrusion/Extrusion 12 12
Material Fragmentation 12 12
Loss of or Failure to Bond 12 12
Device Contamination with Body Fluid 11 11
Dent in Material 11 11
Free or Unrestricted Flow 11 11
Material Twisted/Bent 11 11
Separation Failure 10 10
Stretched 9 9
Material Separation 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
Gas/Air Leak 7 7
Increase in Pressure 6 6
Component Incompatible 6 6
Peeled/Delaminated 6 6
Inflation Problem 6 6
Flaked 6 6
Disconnection 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 25364 25364
No Consequences Or Impact To Patient 491 491
No Known Impact Or Consequence To Patient 447 447
Insufficient Information 239 239
Hemorrhage/Bleeding 145 145
No Patient Involvement 97 97
Perforation 90 90
Bowel Perforation 59 59
Laceration(s) 34 34
Pain 23 23
Injury 21 21
Foreign Body In Patient 20 20
Unspecified Infection 20 20
Abdominal Pain 18 18
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
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
Discomfort 4 4
Unspecified Gastrointestinal Problem 4 4
Drug Resistant Bacterial Infection 4 4
Pancreatitis 4 4
Viral Infection 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
Peritonitis 3 3
Rupture 3 3
Pneumonia 3 3
Ulcer 3 3
Gastrointestinal Hemorrhage 3 3
Constipation 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Swelling/ Edema 2 2
Chills 2 2
Increased Respiratory Rate 2 2
Shaking/Tremors 2 2
No Information 2 2
Abdominal Distention 2 2
Septic Shock 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
Skin Erosion 1 1
Sepsis 1 1
Burning Sensation 1 1
Excessive Tear Production 1 1
Stenosis 1 1
Malaise 1 1
Skin Inflammation 1 1
Low Oxygen Saturation 1 1
Patient Problem/Medical Problem 1 1
Sleep Dysfunction 1 1
Caustic/Chemical Burns 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
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
-
-