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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 A/S
  SUBSTANTIALLY EQUIVALENT 1
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 1497 1497

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 1980 1980
Loss of or Failure to Bond 1694 1694
Microbial Contamination of Device 1693 1693
Break 1158 1158
Detachment of Device or Device Component 1078 1078
Adverse Event Without Identified Device or Use Problem 788 788
Contamination 638 638
Device Reprocessing Problem 606 606
Peeled/Delaminated 379 379
Device Contamination with Chemical or Other Material 341 341
Mechanical Problem 267 267
Contamination /Decontamination Problem 263 263
Fluid/Blood Leak 241 241
Crack 210 210
Use of Device Problem 177 177
Material Separation 158 158
Insufficient Information 145 145
Optical Obstruction 142 142
Optical Problem 110 110
Obstruction of Flow 109 109
Material Split, Cut or Torn 109 109
Mechanical Jam 92 92
Separation Problem 82 82
Corroded 78 78
Material Discolored 68 68
Device Fell 65 65
Poor Quality Image 60 60
Leak/Splash 59 59
Appropriate Term/Code Not Available 56 56
Material Puncture/Hole 36 36
Erratic or Intermittent Display 35 35
No Display/Image 35 35
Material Frayed 29 29
Burst Container or Vessel 29 29
Optical Distortion 29 29
Material Too Rigid or Stiff 28 28
Component Missing 26 26
Physical Resistance/Sticking 25 25
Defective Component 23 23
Optical Discoloration 23 23
Material Twisted/Bent 23 23
Difficult to Advance 22 22
Unintended Movement 22 22
Material Deformation 21 21
Material Integrity Problem 18 18
Device Dislodged or Dislocated 18 18
Improper or Incorrect Procedure or Method 18 18
Complete Blockage 18 18
Degraded 18 18
Partial Blockage 18 18
Entrapment of Device 18 18
Dent in Material 17 17
Device Contamination with Body Fluid 16 16
Suction Problem 16 16
Difficult to Remove 14 14
Structural Problem 14 14
Positioning Problem 14 14
Difficult to Insert 13 13
Loose or Intermittent Connection 12 12
Device Damaged by Another Device 12 12
Device Handling Problem 11 11
Residue After Decontamination 10 10
Positioning Failure 10 10
Collapse 10 10
Device Issue 9 9
Misassembly by Users 9 9
Fracture 8 8
Inflation Problem 8 8
Moisture or Humidity Problem 7 7
Failure to Disconnect 7 7
Blocked Connection 7 7
Deformation Due to Compressive Stress 7 7
Defective Device 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
Patient-Device Incompatibility 4 4
Communication or Transmission Problem 4 4
Tear, Rip or Hole in Device Packaging 4 4
Device-Device Incompatibility 4 4
No Apparent Adverse Event 4 4
Restricted Flow rate 4 4
Unexpected Therapeutic Results 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7241 7241
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 247 254
Foreign Body In Patient 242 242
Hemorrhage/Bleeding 194 194
Unspecified Tissue Injury 184 184
Pancreatitis 161 161
Perforation 115 115
Death 99 99
Laceration(s) 96 96
Inflammation 85 85
Injury 84 84
Unspecified Hepatic or Biliary Problem 78 78
Insufficient Information 73 73
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
Perforation of Esophagus 20 20
Pneumonia 20 20
Bowel Burn 20 20
Internal Organ Perforation 19 19
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
Bowel Perforation 11 11
Cough 10 10
Tissue Damage 10 10
Airway Obstruction 10 10
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
Aspiration Pneumonitis 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

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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