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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
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 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 1

MDR Year MDR Reports MDR Events
2021 2444 2448
2022 8345 8345
2023 11748 11748
2024 12128 12129
2025 17408 17411
2026 6937 6938

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 16178 16179
No Display/Image 5552 5552
Communication or Transmission Problem 5096 5097
Break 4701 4701
Device Reprocessing Problem 4241 4242
Erratic or Intermittent Display 3561 3561
Microbial Contamination of Device 3319 3320
Optical Obstruction 2487 2487
Poor Quality Image 2443 2443
Obstruction of Flow 2425 2425
Fluid/Blood Leak 2199 2199
Detachment of Device or Device Component 1572 1573
Residue After Decontamination 1400 1400
Contamination 1020 1020
Optical Distortion 762 762
Corroded 510 510
Display or Visual Feedback Problem 483 484
Unintended Movement 470 470
Contamination /Decontamination Problem 460 460
Image Display Error/Artifact 354 354
Thermal Decomposition of Device 342 342
Material Split, Cut or Torn 301 301
Adverse Event Without Identified Device or Use Problem 281 281
Melted 277 277
Device Contamination with Chemical or Other Material 276 276
Crack 220 220
Overheating of Device 208 208
Loose or Intermittent Connection 189 189
Output Problem 163 163
Degraded 144 144
Mechanical Problem 133 133
Electrical /Electronic Property Problem 132 132
Component Missing 130 130
Optical Problem 129 129
Connection Problem 121 121
Material Deformation 119 119
Flare or Flash 118 118
Mechanical Jam 111 111
Physical Resistance/Sticking 108 108
Partial Blockage 99 99
Leak/Splash 98 98
Complete Blockage 97 97
Gas/Air Leak 93 93
Improper Flow or Infusion 79 79
Scratched Material 75 75
Fracture 71 71
Material Integrity Problem 69 69
Peeled/Delaminated 63 63
Failure to Power Up 60 60
Material Discolored 59 59

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 58164 58170
Insufficient Information 393 396
Hemorrhage/Bleeding 167 167
Bowel Perforation 99 99
Perforation 76 76
No Consequences Or Impact To Patient 73 73
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 57 57
Laceration(s) 33 33
Abdominal Pain 25 25
Foreign Body In Patient 21 21
Pain 20 20
Fever 19 19
Diarrhea 15 15
Bacterial Infection 14 14
No Patient Involvement 14 14
Internal Organ Perforation 12 12
Abrasion 11 11
Unspecified Tissue Injury 11 11
Unspecified Gastrointestinal Problem 10 10
Gastrointestinal Hemorrhage 9 9
Pancreatitis 9 9
Hematoma 9 9
Unspecified Infection 8 8
Electric Shock 7 7
Device Embedded In Tissue or Plaque 7 7
Unspecified Hepatic or Biliary Problem 6 6
Septic Shock 5 5
Tachycardia 5 5
Low Blood Pressure/ Hypotension 5 5
Granuloma 5 5
Erosion 4 4
Pneumonia 4 4
Viral Infection 4 4
Discomfort 4 4
Drug Resistant Bacterial Infection 4 4
Transmissible Spongiform Encephalopathy(TSE) 3 3
Intra-Abdominal Hemorrhage 3 3
Ulcer 3 3
Distress 3 3
Peritonitis 3 3
Rupture 3 3
Chemical Exposure 3 3
Abdominal Distention 3 3
Hypoxia 3 3
Inflammation 3 3
Hepatitis 3 3
Burn(s) 3 3
Chest Pain 2 2
Bruise/Contusion 2 2
Abscess 2 2

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 Pentax of America Inc II Sep-10-2021
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