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 gastroscope and accessories, flexible/rigid
Regulation Description Endoscope and accessories.
Definition To examine or perform procedures in the stomach. 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 CodeFDS
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
ACTUATED MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALTON (SHANGHAI) MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
AMBU A/S
  SUBSTANTIALLY EQUIVALENT 2
EVOENDO, INC.
  SUBSTANTIALLY EQUIVALENT 3
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
FUJIFILM CORPORATON
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM HEALTHCARE AMERICAS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
IQ ENDOSCOPES LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO., LTD .
  SUBSTANTIALLY EQUIVALENT 1
NEPTUNE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2021 1755 1756
2022 6216 6240
2023 9874 9883
2024 9258 9258
2025 19076 19079

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 15165 15176
Poor Quality Image 4849 4858
Device Reprocessing Problem 3593 3599
No Display/Image 2631 2632
Break 2464 2464
Fluid/Blood Leak 1983 1983
Erratic or Intermittent Display 1909 1909
Obstruction of Flow 1858 1859
Microbial Contamination of Device 1856 1857
Communication or Transmission Problem 1837 1837
Residue After Decontamination 1421 1421
Optical Obstruction 1025 1025
Contamination 1001 1008
Detachment of Device or Device Component 991 991
Thermal Decomposition of Device 674 674
Contamination /Decontamination Problem 535 535
Melted 461 461
Adverse Event Without Identified Device or Use Problem 442 444
Device Contamination with Chemical or Other Material 436 436
Corroded 394 394
Image Display Error/Artifact 374 375
Optical Distortion 345 345
Flare or Flash 302 302
Misfocusing 298 298
Overheating of Device 277 277
Unintended Movement 196 196
Display or Visual Feedback Problem 184 186
Material Split, Cut or Torn 172 172
Crack 149 149
Material Deformation 143 143
Component Missing 131 131
Loose or Intermittent Connection 131 131
Degraded 115 115
Gas/Air Leak 111 111
Peeled/Delaminated 93 94
Scratched Material 89 89
Material Discolored 88 88
Optical Problem 84 84
Improper Flow or Infusion 81 81
Mechanical Problem 80 80
Partial Blockage 80 80
Collapse 78 78
Electrical /Electronic Property Problem 76 76
Positioning Failure 72 72
Leak/Splash 69 69
Physical Resistance/Sticking 68 68
Complete Blockage 66 66
Excessive Heating 62 62
Mechanical Jam 59 59
Material Integrity Problem 56 56

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 45215 45249
Insufficient Information 265 265
Hemorrhage/Bleeding 220 222
Perforation 158 158
Foreign Body In Patient 102 103
No Consequences Or Impact To Patient 71 71
Bacterial Infection 58 58
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 48 48
Fever 42 42
Unspecified Infection 35 35
Drug Resistant Bacterial Infection 30 30
Gastrointestinal Hemorrhage 30 30
Bowel Perforation 26 26
Abdominal Pain 23 23
Pancreatitis 21 21
Unspecified Tissue Injury 21 21
No Patient Involvement 18 18
Pain 18 18
Unspecified Hepatic or Biliary Problem 17 17
Peritonitis 16 16
Chest Pain 15 15
Stenosis 14 14
Sepsis 12 12
Pneumothorax 12 12
Unspecified Gastrointestinal Problem 11 11
Laceration(s) 11 11
Abscess 9 9
Pleural Effusion 8 8
Fistula 8 8
Perforation of Esophagus 8 8
Stenosis of the esophagus 7 7
Chills 7 7
Internal Organ Perforation 7 7
Pneumonia 7 7
Laceration(s) of Esophagus 7 7
Malaise 7 7
Nausea 7 7
Abrasion 6 6
Muscle/Tendon Damage 6 6
Swelling/ Edema 6 6
Pulmonary Emphysema 5 5
Unspecified Respiratory Problem 5 5
Aspiration Pneumonitis 5 5
Chemical Exposure 4 4
Hematoma 4 4
Thrombosis/Thrombus 4 4
Hematemesis 4 4
Fungal Infection 4 4
Viral Infection 4 4
Respiratory Tract Infection 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Aomori Olympus Co., Ltd. II Sep-07-2023
2 Olympus Corporation of the Americas II Dec-05-2024
3 Olympus Corporation of the Americas II Nov-20-2024
4 Olympus Corporation of the Americas II Jun-21-2022
-
-