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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
Regulation Description Endoscope and accessories.
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
ENDOROBOTICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ERA ENDOSCOPY S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
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 3
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SANESO, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI SEEGEN PHOTOELECTRIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMART MEDICAL SYSTEMS , LTD.
  SUBSTANTIALLY EQUIVALENT 3
YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 687 687
2021 2444 2448
2022 8345 8345
2023 11748 11748
2024 12128 12129
2025 17408 17411
2026 16640 16644

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 19649 19651
No Display/Image 6876 6876
Communication or Transmission Problem 6772 6774
Break 4789 4789
Device Reprocessing Problem 4567 4568
Erratic or Intermittent Display 4184 4184
Microbial Contamination of Device 3949 3950
Poor Quality Image 3725 3725
Optical Obstruction 2553 2553
Obstruction of Flow 2458 2458
Fluid/Blood Leak 2270 2270
Residue After Decontamination 1818 1818
Detachment of Device or Device Component 1643 1644
Contamination 1069 1069
Corroded 955 955
Optical Distortion 765 765
Display or Visual Feedback Problem 522 523
Contamination /Decontamination Problem 508 508
Unintended Movement 474 474
Image Display Error/Artifact 409 409
Melted 365 365
Thermal Decomposition of Device 365 365
Adverse Event Without Identified Device or Use Problem 319 319
Device Contamination with Chemical or Other Material 318 318
Overheating of Device 312 312
Material Split, Cut or Torn 312 312
Crack 233 233
Output Problem 209 210
Loose or Intermittent Connection 200 200
Connection Problem 174 174
Degraded 170 170
Mechanical Problem 144 144
Material Deformation 141 141
Electrical /Electronic Property Problem 139 139
Optical Problem 137 137
Flare or Flash 135 135
Mechanical Jam 133 133
Component Missing 131 131
Physical Resistance/Sticking 131 131
Partial Blockage 110 110
Leak/Splash 108 108
Complete Blockage 107 107
Gas/Air Leak 101 101
Improper Flow or Infusion 79 79
Scratched Material 77 77
Material Integrity Problem 77 77
Fracture 73 73
Failure to Power Up 65 65
Peeled/Delaminated 64 64
Material Discolored 64 64

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 67855 67864
No Consequences Or Impact To Patient 432 432
Insufficient Information 419 422
No Known Impact Or Consequence To Patient 190 190
Hemorrhage/Bleeding 169 169
Bowel Perforation 111 111
No Patient Involvement 88 88
Perforation 88 88
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 62 62
Laceration(s) 35 35
Abdominal Pain 28 28
Pain 26 26
Foreign Body In Patient 22 22
Fever 19 19
Bacterial Infection 16 16
Unspecified Infection 16 16
Diarrhea 15 15
Abrasion 13 13
Internal Organ Perforation 12 12
Unspecified Tissue Injury 12 12
Injury 12 12
Gastrointestinal Hemorrhage 11 11
Unspecified Gastrointestinal Problem 10 10
Pancreatitis 9 9
Hematoma 9 9
Electric Shock 9 9
Device Embedded In Tissue or Plaque 8 8
Septic Shock 7 7
Bruise/Contusion 6 6
Unspecified Hepatic or Biliary Problem 6 6
Viral Infection 6 6
Low Blood Pressure/ Hypotension 5 5
Granuloma 5 5
Tachycardia 5 5
Blood Loss 5 5
Abscess 5 5
Discomfort 5 5
Burn(s) 5 5
Drug Resistant Bacterial Infection 4 4
No Code Available 4 4
Erosion 4 4
Tissue Damage 4 4
Rupture 4 4
Pneumonia 4 4
Peritonitis 4 4
Distress 3 3
Fistula 3 3
Ulcer 3 3
Hypoxia 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 Olympus Corporation of the Americas II Oct-11-2024
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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