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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device duodenoscope and accessories, flexible/rigid
Definition To examine the duodenum and to perform various procedures within the duodenum. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type 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 CodeFDT
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
AMBU INNOVATION GMBH
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 4
PENTAX MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
PENTAX MEDICAL COMPANY
  SUBSTANTIALLY EQUIVALENT 1
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2014 35 35
2015 246 246
2016 247 247
2017 791 791
2018 481 481
2019 1347 1347
2020 822 822
2021 1270 1270
2022 2619 2619
2023 3050 3050
2024 1006 1006

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 1759 1759
Loss of or Failure to Bond 1694 1694
Microbial Contamination of Device 1670 1670
Break 1129 1129
Detachment of Device or Device Component 1012 1012
Adverse Event Without Identified Device or Use Problem 782 782
Contamination 635 635
Device Reprocessing Problem 576 576
Peeled/Delaminated 371 371
Device Contamination with Chemical or Other Material 341 341
Mechanical Problem 264 264
Contamination /Decontamination Problem 263 263
Fluid/Blood Leak 235 235
Crack 199 199
Use of Device Problem 177 177
Material Separation 146 146
Insufficient Information 145 145
Optical Obstruction 127 127
Material Split, Cut or Torn 104 104
Optical Problem 102 102
Obstruction of Flow 97 97
Mechanical Jam 91 91
Separation Problem 82 82
Corroded 69 69
Device Fell 65 65
Appropriate Term/Code Not Available 56 56
Material Discolored 55 55
Leak/Splash 55 55
Poor Quality Image 55 55
No Display/Image 34 34
Material Puncture/Hole 32 32
Erratic or Intermittent Display 29 29
Optical Distortion 29 29
Material Frayed 28 28
Component Missing 26 26
Burst Container or Vessel 24 24
Material Too Rigid or Stiff 24 24
Physical Resistance/Sticking 24 24
Material Twisted/Bent 23 23
Unintended Movement 22 22
Difficult to Advance 22 22
Material Deformation 21 21
Defective Component 21 21
Improper or Incorrect Procedure or Method 18 18
Partial Blockage 18 18
Device Dislodged or Dislocated 18 18
Material Integrity Problem 17 17
Dent in Material 17 17
Complete Blockage 17 17
Degraded 16 16
Entrapment of Device 16 16
Suction Problem 16 16
Device Contamination with Body Fluid 16 16
Optical Discoloration 15 15
Structural Problem 14 14
Difficult to Remove 14 14
Positioning Problem 13 13
Loose or Intermittent Connection 12 12
Difficult to Insert 11 11
Device Handling Problem 11 11
Residue After Decontamination 10 10
Device Damaged by Another Device 10 10
Positioning Failure 10 10
Collapse 10 10
Device Issue 9 9
Misassembly by Users 9 9
Fracture 8 8
Inflation Problem 7 7
Failure to Disconnect 7 7
Defective Device 7 7
Blocked Connection 7 7
Deformation Due to Compressive Stress 7 7
Contamination of Device Ingredient or Reagent 6 6
Activation, Positioning or Separation Problem 6 6
Failure to Advance 6 6
Scratched Material 6 6
Problem with Sterilization 6 6
Display or Visual Feedback Problem 6 6
Sharp Edges 6 6
Design/structure problem 5 5
Migration or Expulsion of Device 5 5
Material Protrusion/Extrusion 5 5
Electrical Shorting 5 5
Device Operates Differently Than Expected 5 5
Device Contamination With Biological Material 4 4
Communication or Transmission Problem 4 4
Patient-Device Incompatibility 4 4
Device-Device Incompatibility 4 4
Moisture or Humidity Problem 4 4
No Apparent Adverse Event 4 4
Unexpected Therapeutic Results 4 4
Restricted Flow rate 4 4
Image Display Error/Artifact 4 4
Premature Separation 4 4
Failure to Eject 3 3
Device Contaminated at the User Facility 3 3
Flushing Problem 3 3
Electrical /Electronic Property Problem 3 3
Failure to Disinfect 3 3
Difficult or Delayed Positioning 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6762 6762
No Known Impact Or Consequence To Patient 2084 2084
No Consequences Or Impact To Patient 707 707
Bacterial Infection 495 495
No Patient Involvement 356 356
Unspecified Infection 244 251
Foreign Body In Patient 240 240
Hemorrhage/Bleeding 191 191
Unspecified Tissue Injury 184 184
Pancreatitis 158 158
Perforation 115 115
Death 99 99
Laceration(s) 91 91
Inflammation 85 85
Injury 84 84
Unspecified Hepatic or Biliary Problem 78 78
Insufficient Information 70 70
Device Embedded In Tissue or Plaque 59 59
No Code Available 55 55
Fever 38 38
Abdominal Pain 31 31
Sepsis 27 27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 27 27
Laceration(s) of Esophagus 23 23
Pneumonia 20 20
Bowel Burn 20 20
Perforation of Esophagus 19 19
Internal Organ Perforation 17 17
Pain 16 16
Vomiting 16 16
Abscess 16 16
Blood Loss 15 15
No Information 13 13
Tissue Breakdown 12 12
Septic Shock 12 12
Tissue Damage 10 10
Airway Obstruction 10 10
Cough 10 10
Bowel Perforation 9 9
Fungal Infection 8 8
Obstruction/Occlusion 7 7
Abrasion 7 7
Low Blood Pressure/ Hypotension 7 7
Not Applicable 7 7
Cancer 6 6
Drug Resistant Bacterial Infection 6 6
Gastrointestinal Hemorrhage 6 6
Fistula 6 6
Nausea 5 5
Cardiac Arrest 5 5
Low Oxygen Saturation 5 5
Complaint, Ill-Defined 5 5
Peritonitis 5 5
Patient Problem/Medical Problem 5 5
Unspecified Gastrointestinal Problem 4 4
Adult Respiratory Distress Syndrome 4 4
Liver Damage/Dysfunction 3 3
High Blood Pressure/ Hypertension 3 3
Dysphagia/ Odynophagia 3 3
Hematoma 3 3
Scar Tissue 3 3
Chills 3 3
Swelling/ Edema 3 3
Thrombosis/Thrombus 3 3
Test Result 3 3
Needle Stick/Puncture 2 2
Thromboembolism 2 2
Pseudoaneurysm 2 2
Weight Changes 2 2
Heart Failure/Congestive Heart Failure 2 2
Respiratory Arrest 2 2
Weakness 2 2
Shock 2 2
Ulcer 2 2
Anxiety 2 2
Distress 2 2
Discomfort 2 2
Sore Throat 2 2
Loss of consciousness 2 2
Fatigue 2 2
Exposure to Body Fluids 2 2
Diarrhea 2 2
Purulent Discharge 1 1
Dehydration 1 1
Chest Pain 1 1
Burn(s) 1 1
Calcium Deposits/Calcification 1 1
Bruise/Contusion 1 1
Aspiration/Inhalation 1 1
Air Embolism 1 1
Hemostasis 1 1
Hemothorax 1 1
Extreme Exhaustion 1 1
Headache 1 1
Necrosis 1 1
Diaphoresis 1 1
Shaking/Tremors 1 1
Cognitive Changes 1 1
Electric Shock 1 1
Joint Dislocation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Nov-21-2023
2 Boston Scientific Corporation II May-13-2022
3 Boston Scientific Corporation III Apr-26-2021
4 Fujifilm Medical Systems U.S.A., Inc. II Sep-27-2017
5 Fujifilm Medical Systems U.S.A., Inc. II Sep-13-2017
6 Fujifilm Medical Systems U.S.A., Inc. II May-31-2016
7 Fujifilm Medical Systems U.S.A., Inc. II Dec-15-2015
8 Fujifilm Medical Systems U.S.A., Inc. II Sep-17-2015
9 Olympus America Inc. II Sep-22-2015
10 Olympus Corporation of the Americas II Feb-09-2024
11 Olympus Corporation of the Americas II Aug-28-2023
12 Olympus Corporation of the Americas II May-19-2023
13 Olympus Corporation of the Americas II Dec-10-2021
14 Olympus Corporation of the Americas II Mar-22-2021
15 Olympus Corporation of the Americas II May-31-2016
16 Olympus Corporation of the Americas II Feb-04-2016
17 Pentax Medical Company II Jul-23-2016
18 Pentax Medical Company II May-27-2016
19 Pentax of America Inc II May-25-2021
20 Pentax of America Inc II Feb-20-2018
21 Pentax of America Inc II Jul-11-2017
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