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
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
AMBU A/S
  SUBSTANTIALLY EQUIVALENT 2
EASYGLIDE LTD.
  SUBSTANTIALLY EQUIVALENT 2
ENDOCHOICE INC.
  SUBSTANTIALLY EQUIVALENT 1
ENDOCHOICE, INC.
  SUBSTANTIALLY EQUIVALENT 1
EVOENDO INC
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 10
FUJIFILM CORPORATON
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM HEALTHCARE AMERICAS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 2
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJINON INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJINON, INC.
  SUBSTANTIALLY EQUIVALENT 1
GI SCIENTIFIC LLC
  SUBSTANTIALLY EQUIVALENT 1
HUIZHOU XZING TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
IQ ENDOSCOPES LIMITED
  SUBSTANTIALLY EQUIVALENT 1
NEPTUNE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PENTAX MEDICAL COMPANY
  SUBSTANTIALLY EQUIVALENT 1
PENTAX MEDICAL OF AMERICA, INC
  SUBSTANTIALLY EQUIVALENT 1
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 3
SUMITOMO BAKELITE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES ENDOSCOPY GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
VISURA TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 23 23
2015 28 28
2016 108 108
2017 178 178
2018 304 304
2019 1376 1376
2020 601 601
2021 1755 1755
2022 6216 6216
2023 9873 9873
2024 4126 4126

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 7995 7995
Break 2305 2305
Microbial Contamination of Device 2073 2073
Poor Quality Image 2003 2003
Device Reprocessing Problem 1696 1696
Fluid/Blood Leak 1687 1687
Obstruction of Flow 1157 1157
Erratic or Intermittent Display 859 859
Contamination 811 811
No Display/Image 708 708
Detachment of Device or Device Component 677 677
Optical Obstruction 604 604
Device Contamination with Chemical or Other Material 470 470
Adverse Event Without Identified Device or Use Problem 464 464
Contamination /Decontamination Problem 449 449
Optical Distortion 335 335
Unintended Movement 179 179
Component Missing 131 131
Material Split, Cut or Torn 91 91
Display or Visual Feedback Problem 90 90
Loose or Intermittent Connection 82 82
Image Display Error/Artifact 81 81
Partial Blockage 69 69
Mechanical Problem 64 64
Leak/Splash 61 61
Collapse 50 50
Communication or Transmission Problem 41 41
Improper or Incorrect Procedure or Method 37 37
Failure to Disconnect 34 34
Fracture 34 34
Physical Resistance/Sticking 33 33
Optical Problem 31 31
Insufficient Information 30 30
Material Too Rigid or Stiff 30 30
Suction Problem 29 29
Peeled/Delaminated 29 29
Complete Blockage 28 28
Device Handling Problem 28 28
Device Damaged by Another Device 27 27
Material Deformation 25 25
Corroded 23 23
Loss of or Failure to Bond 22 22
Appropriate Term/Code Not Available 21 21
Use of Device Problem 20 20
Crack 19 19
Mechanical Jam 18 18
Deformation Due to Compressive Stress 18 18
Scratched Material 18 18
Moisture Damage 16 16
Electrical /Electronic Property Problem 15 15
Degraded 14 14
Residue After Decontamination 14 14
Failure to Disinfect 13 13
Optical Discoloration 13 13
Failure to Align 12 12
Dent in Material 12 12
Insufficient Flow or Under Infusion 11 11
Material Separation 11 11
Gas/Air Leak 11 11
Device Contamination with Body Fluid 10 10
Defective Component 9 9
Separation Failure 9 9
Material Protrusion/Extrusion 9 9
Connection Problem 9 9
Labelling, Instructions for Use or Training Problem 9 9
Blocked Connection 8 8
Device Dislodged or Dislocated 8 8
Electrical Overstress 8 8
Material Twisted/Bent 8 8
Problem with Sterilization 8 8
Sticking 7 7
Material Integrity Problem 7 7
Moisture or Humidity Problem 7 7
Infusion or Flow Problem 7 7
Reflux within Device 7 7
Failure to Eject 7 7
Device Fell 7 7
Separation Problem 7 7
Device Contaminated at the User Facility 6 6
Sharp Edges 6 6
Difficult to Remove 6 6
Overheating of Device 6 6
Difficult to Insert 6 6
Material Fragmentation 5 5
Misconnection 5 5
Material Discolored 5 5
Material Perforation 5 5
Device Issue 5 5
Noise, Audible 5 5
Pressure Problem 5 5
Output Problem 4 4
Ventilation Problem in Device Environment 4 4
Key or Button Unresponsive/not Working 4 4
Defective Device 4 4
Difficult to Open or Close 4 4
Device-Device Incompatibility 4 4
Disconnection 4 4
Difficult or Delayed Positioning 4 4
Entrapment of Device 4 4
Detachment Of Device Component 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21314 21314
No Known Impact Or Consequence To Patient 1766 1766
No Consequences Or Impact To Patient 558 558
Hemorrhage/Bleeding 176 176
Perforation 170 170
Insufficient Information 157 157
No Patient Involvement 134 134
Foreign Body In Patient 107 107
Bacterial Infection 56 56
Injury 44 44
Unspecified Infection 40 40
Drug Resistant Bacterial Infection 27 27
Fever 26 26
Unspecified Hepatic or Biliary Problem 17 17
No Code Available 17 17
Laceration(s) 16 16
Abdominal Pain 16 16
Pain 16 16
Pancreatitis 15 15
Unspecified Tissue Injury 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Stenosis 14 14
Inflammation 14 14
No Information 13 13
Sepsis 12 12
Abrasion 11 11
Bowel Perforation 11 11
Peritonitis 10 10
Unspecified Gastrointestinal Problem 10 10
Abscess 10 10
Chest Pain 10 10
Gastrointestinal Hemorrhage 9 9
Chemical Exposure 8 8
Chills 8 8
Laceration(s) of Esophagus 8 8
Perforation of Esophagus 7 7
Malaise 7 7
Pneumonia 7 7
Death 7 7
Burn(s) 7 7
Pneumothorax 6 6
Nausea 6 6
Muscle/Tendon Damage 6 6
Swelling/ Edema 5 5
Blood Loss 5 5
Internal Organ Perforation 5 5
Vomiting 5 5
Exposure to Body Fluids 5 5
Diarrhea 4 4
Fistula 4 4
Hematoma 4 4
Viral Infection 4 4
Therapeutic Effects, Unexpected 4 4
Tissue Damage 4 4
Respiratory Tract Infection 4 4
Thrombosis/Thrombus 4 4
Unspecified Respiratory Problem 4 4
Patient Problem/Medical Problem 4 4
Multiple Organ Failure 3 3
Aspiration Pneumonitis 3 3
Hematemesis 3 3
Fungal Infection 3 3
Ulcer 3 3
Liver Failure 3 3
Shock 3 3
Pleural Effusion 3 3
Hypersensitivity/Allergic reaction 3 3
Air Embolism 3 3
Pulmonary Embolism 3 3
Aspiration/Inhalation 2 2
Wound Dehiscence 2 2
Cardiac Arrest 2 2
Eye Injury 2 2
Hyperbilirubinemia 2 2
Hyperemia 2 2
Burning Sensation 2 2
Transmissible Spongiform Encephalopathy(TSE) 2 2
Abdominal Distention 2 2
Shaking/Tremors 2 2
Electric Shock 2 2
Gastroesophageal Burn 2 2
Cancer 2 2
Vascular Dissection 2 2
Device Embedded In Tissue or Plaque 2 2
Unspecified Mental, Emotional or Behavioural Problem 1 1
Embolism/Embolus 1 1
Melena 1 1
Cough 1 1
Unspecified Eye / Vision Problem 1 1
Ascites 1 1
Discomfort 1 1
Obstruction/Occlusion 1 1
Needle Stick/Puncture 1 1
Low Oxygen Saturation 1 1
Organ Dehiscence 1 1
Stenosis of the esophagus 1 1
Skin Inflammation/ Irritation 1 1
Genital Bleeding 1 1
Mediastinal Shift 1 1
Excessive Tear Production 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aomori Olympus Co., Ltd. II Sep-07-2023
2 Fujifilm Medical Systems U.S.A., Inc. II Jul-10-2017
3 Fujinon Inc II Oct-30-2013
4 Olympus Corporation of the Americas II Jun-21-2022
5 Olympus Corporation of the Americas II Nov-27-2020
6 Pentax Medical Company II Jun-28-2016
7 Pentax Medical Company II Jul-24-2014
8 Pentax of America Inc II Oct-26-2016
-
-