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
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 2
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
YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHNOLOGY CO., 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 20001 20005

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 20948 20950
No Display/Image 7240 7240
Communication or Transmission Problem 7207 7209
Break 4742 4742
Device Reprocessing Problem 4632 4633
Erratic or Intermittent Display 4339 4339
Poor Quality Image 4112 4112
Microbial Contamination of Device 3755 3756
Optical Obstruction 2568 2568
Obstruction of Flow 2467 2467
Fluid/Blood Leak 2276 2276
Residue After Decontamination 2097 2097
Detachment of Device or Device Component 1647 1648
Corroded 1087 1087
Contamination 1076 1076
Optical Distortion 764 764
Display or Visual Feedback Problem 526 526
Contamination /Decontamination Problem 498 498
Unintended Movement 474 474
Image Display Error/Artifact 415 415
Melted 395 395
Thermal Decomposition of Device 381 381
Overheating of Device 372 372
Material Split, Cut or Torn 316 316
Device Contamination with Chemical or Other Material 281 281
Adverse Event Without Identified Device or Use Problem 257 257
Crack 242 242
Output Problem 221 222
Loose or Intermittent Connection 204 204
Connection Problem 186 186
Degraded 180 180
Material Deformation 145 145
Flare or Flash 145 145
Optical Problem 142 142
Electrical /Electronic Property Problem 138 138
Mechanical Jam 136 136
Physical Resistance/Sticking 136 136
Component Missing 130 130
Mechanical Problem 130 130
Complete Blockage 109 109
Gas/Air Leak 108 108
Partial Blockage 107 107
Leak/Splash 101 101
Scratched Material 81 81
Improper Flow or Infusion 81 81
Material Integrity Problem 76 76
Fracture 75 75
Material Discolored 68 68
Peeled/Delaminated 67 67
Failure to Power Up 62 62

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 71178 71187
Insufficient Information 422 425
Hemorrhage/Blood Loss/Bleeding 169 169
Bowel Perforation 109 109
Perforation 83 83
No Consequences Or Impact To Patient 73 73
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 63 63
Laceration(s) 35 35
Abdominal Pain 27 27
Pain 22 22
Foreign Body In Patient 21 21
Fever 19 19
Diarrhea 15 15
No Patient Involvement 14 14
Bacterial Infection 14 14
Internal Organ Perforation 12 12
Unspecified Infection 12 12
Unspecified Tissue Injury 12 12
Abrasion 11 11
Gastrointestinal Hemorrhage 11 11
Unspecified Gastrointestinal Problem 10 10
Hematoma 9 9
Pancreatitis 9 9
Device Embedded In Tissue or Plaque 7 7
Electric Shock 7 7
Unspecified Hepatic or Biliary Problem 6 6
Viral Infection 6 6
Cholangitis 5 5
Abscess 5 5
Septic Shock 5 5
Low Blood Pressure/ Hypotension 5 5
Tachycardia 5 5
Granuloma 5 5
Bacteremia 5 5
Burn(s) 5 5
Peritonitis 4 4
Drug Resistant Bacterial Infection 4 4
Pneumonia 4 4
Erosion 4 4
Discomfort 4 4
Chemical Exposure 3 3
Hypoxia 3 3
Ulcer 3 3
Rupture 3 3
Inflammation 3 3
Transmissible Spongiform Encephalopathy(TSE) 3 3
Malaise 3 3
Fistula 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 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
-
-