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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stents, drains and dilators for the biliary ducts
Product CodeFGE
Regulation Number 876.5010
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOTEQUE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORPORATION
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 2
BRIGHTWATER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
COOK IRELAND LTD
  SUBSTANTIALLY EQUIVALENT 1
COOK IRELAND LTD.
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN TT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENDO GI MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ENDOGI MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ENDOGI MEDICAL, LTD.
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
M.I.TECH CO., LTD.
  SE - WITH LIMITATIONS 2
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
S&G BIOTECH INC.
  SE - WITH LIMITATIONS 1
TAEWOONG MEDICAL CO., LTD
  SE - WITH LIMITATIONS 2

MDR Year MDR Reports MDR Events
2019 1895 1895
2020 2181 2181
2021 2297 2297
2022 1749 1749
2023 1624 1624
2024 877 877

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 2326 2326
Break 993 993
Improper or Incorrect Procedure or Method 834 834
Material Puncture/Hole 773 773
Adverse Event Without Identified Device or Use Problem 742 742
Material Deformation 655 655
Burst Container or Vessel 606 606
Off-Label Use 543 543
Detachment of Device or Device Component 453 453
Difficult to Remove 418 418
Migration 369 369
Device Dislodged or Dislocated 354 354
Activation, Positioning or Separation Problem 350 350
Use of Device Problem 291 291
Difficult to Advance 290 290
Positioning Failure 251 251
Leak/Splash 243 243
Activation Failure 243 243
Fracture 212 212
Material Twisted/Bent 208 208
Dent in Material 197 197
Premature Activation 181 181
Inflation Problem 148 148
Difficult or Delayed Positioning 144 144
Entrapment of Device 135 135
Failure to Advance 134 134
Material Integrity Problem 102 102
Material Separation 99 99
Obstruction of Flow 97 97
Positioning Problem 94 94
Physical Resistance/Sticking 87 87
Deflation Problem 77 77
Migration or Expulsion of Device 72 72
Material Split, Cut or Torn 71 71
Defective Device 66 66
Deformation Due to Compressive Stress 63 63
Mechanical Jam 62 62
Appropriate Term/Code Not Available 55 55
Stretched 51 51
Difficult or Delayed Activation 49 49
Crack 48 48
Defective Component 47 47
Fluid/Blood Leak 46 46
Device Damaged Prior to Use 44 44
Tear, Rip or Hole in Device Packaging 43 43
Unsealed Device Packaging 42 42
Retraction Problem 41 41
Malposition of Device 41 41
Device-Device Incompatibility 38 38
Insufficient Information 31 31
Failure to Deflate 30 30
Device Contamination with Chemical or Other Material 27 27
Material Protrusion/Extrusion 26 26
Device Contaminated During Manufacture or Shipping 26 26
Therapy Delivered to Incorrect Body Area 25 25
Difficult to Insert 25 25
Loss of or Failure to Bond 21 21
Device Damaged by Another Device 20 20
Device Markings/Labelling Problem 20 20
Device Stenosis 18 18
Partial Blockage 18 18
Material Fragmentation 17 17
No Apparent Adverse Event 16 16
Packaging Problem 15 15
Complete Blockage 15 15
Material Frayed 14 14
Structural Problem 14 14
Problem with Sterilization 14 14
Unintended Movement 14 14
Component Missing 13 13
Material Perforation 12 12
Misfire 12 12
Activation Problem 11 11
Mechanical Problem 10 10
Unraveled Material 9 9
Contamination 7 7
Difficult to Open or Remove Packaging Material 7 7
Separation Failure 6 6
Patient-Device Incompatibility 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Product Quality Problem 6 6
Peeled/Delaminated 5 5
Unintended Ejection 5 5
Patient Device Interaction Problem 5 5
Poor Visibility 5 5
Separation Problem 4 4
Device Handling Problem 4 4
Gas/Air Leak 4 4
Human-Device Interface Problem 4 4
Material Disintegration 4 4
Inadequacy of Device Shape and/or Size 4 4
Device Slipped 3 3
Nonstandard Device 3 3
Delivered as Unsterile Product 3 3
Device Difficult to Setup or Prepare 3 3
Failure to Align 3 3
Calcified 3 3
Infusion or Flow Problem 3 3
Difficult to Open or Close 3 3
Contamination /Decontamination Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5844 5844
No Consequences Or Impact To Patient 2786 2786
No Known Impact Or Consequence To Patient 800 800
Insufficient Information 229 229
Obstruction/Occlusion 210 210
Perforation 163 163
Inflammation 161 161
Foreign Body In Patient 155 155
Hemorrhage/Bleeding 121 121
No Patient Involvement 97 97
No Code Available 81 81
Pancreatitis 79 79
Pain 75 75
Occlusion 66 66
Device Embedded In Tissue or Plaque 64 64
Abdominal Pain 55 55
Thrombosis/Thrombus 54 54
Stenosis 54 54
Vascular Dissection 49 49
Restenosis 45 45
Unspecified Infection 41 41
Patient Problem/Medical Problem 40 40
Sepsis 36 36
Hematoma 36 36
Fever 35 35
Abscess 33 33
Blood Loss 33 33
Reocclusion 30 30
Failure of Implant 28 28
Jaundice 27 27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 27 27
Thrombosis 25 25
Injury 23 23
No Information 23 23
Pseudoaneurysm 21 21
Death 21 21
Peritonitis 20 20
Bowel Perforation 18 18
Ischemia 17 17
Renal Failure 15 15
Rupture 14 14
Discomfort 14 14
Aneurysm 14 14
Unspecified Tissue Injury 14 14
Embolism 13 13
Thrombus 13 13
Perforation of Vessels 13 13
Vomiting 13 13
Embolism/Embolus 12 12
Fistula 12 12
Stroke/CVA 11 11
Unspecified Hepatic or Biliary Problem 11 11
Myocardial Infarction 10 10
Bacterial Infection 9 9
Erosion 9 9
Pneumonia 8 8
Low Blood Pressure/ Hypotension 8 8
Swelling/ Edema 8 8
Gastrointestinal Hemorrhage 7 7
Nausea 7 7
Laceration(s) 6 6
Hyperbilirubinemia 6 6
Arrhythmia 6 6
Septic Shock 6 6
Unintended Radiation Exposure 6 6
Urinary Tract Infection 5 5
Cardiac Arrest 5 5
Hemoptysis 5 5
Internal Organ Perforation 5 5
Pleural Effusion 4 4
Chest Pain 4 4
Aspiration/Inhalation 4 4
Bradycardia 4 4
Intimal Dissection 4 4
Complaint, Ill-Defined 4 4
Fluid Discharge 4 4
Claudication 4 4
Abdominal Distention 3 3
Great Vessel Perforation 3 3
Respiratory Insufficiency 3 3
Unspecified Vascular Problem 3 3
Diaphoresis 3 3
Aortic Dissection 3 3
Ulcer 3 3
Shock 3 3
Pulmonary Embolism 3 3
Pneumothorax 3 3
Rash 3 3
Necrosis 3 3
Hypersensitivity/Allergic reaction 3 3
High Blood Pressure/ Hypertension 3 3
Fatigue 3 3
Infiltration into Tissue 2 2
Pulmonary Edema 2 2
Abrasion 2 2
Vessel Or Plaque, Device Embedded In 2 2
Anemia 2 2
Biliary Cirrhosis 2 2
Congestive Heart Failure 2 2
Cellulitis 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Aomori Olympus Co., Ltd. II Feb-05-2021
2 Boston Scientific Corporation II Dec-01-2021
3 Boston Scientific Corporation II Oct-23-2020
4 Boston Scientific Corporation II Sep-12-2020
5 Boston Scientific Corporation II Nov-25-2019
6 Boston Scientific Corporation II Jul-09-2019
7 Boston Scientific Corporation II Mar-14-2019
8 Cook Inc. II Feb-28-2019
9 Cook Incorporated II Jun-27-2024
10 Cook Incorporated II Apr-12-2024
11 Cordis Corporation II Nov-12-2021
12 Cordis US Corp II Jul-11-2022
13 Hobbs Medical, Inc. II Oct-07-2022
14 Olympus Corporation of the Americas II Jan-31-2024
15 W.L. Gore & Associates, Inc. II Feb-22-2024
16 W.L. Gore & Associates, Inc. II May-14-2021
17 Wilson-Cook Medical Inc. II Dec-01-2023
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