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 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
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 376 376

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 2223 2223
Break 913 913
Improper or Incorrect Procedure or Method 795 795
Material Puncture/Hole 763 763
Adverse Event Without Identified Device or Use Problem 702 702
Material Deformation 622 622
Burst Container or Vessel 577 577
Off-Label Use 529 529
Detachment of Device or Device Component 425 425
Difficult to Remove 403 403
Migration 355 355
Activation, Positioning or Separation Problem 342 342
Device Dislodged or Dislocated 337 337
Difficult to Advance 271 271
Use of Device Problem 263 263
Activation Failure 237 237
Leak/Splash 233 233
Positioning Failure 229 229
Fracture 210 210
Material Twisted/Bent 196 196
Dent in Material 182 182
Premature Activation 171 171
Inflation Problem 143 143
Difficult or Delayed Positioning 132 132
Failure to Advance 126 126
Entrapment of Device 119 119
Material Integrity Problem 100 100
Obstruction of Flow 95 95
Material Separation 94 94
Positioning Problem 90 90
Physical Resistance/Sticking 83 83
Deflation Problem 76 76
Migration or Expulsion of Device 70 70
Defective Device 63 63
Mechanical Jam 60 60
Material Split, Cut or Torn 59 59
Appropriate Term/Code Not Available 55 55
Deformation Due to Compressive Stress 54 54
Difficult or Delayed Activation 49 49
Crack 47 47
Stretched 46 46
Tear, Rip or Hole in Device Packaging 43 43
Defective Component 42 42
Unsealed Device Packaging 41 41
Device Damaged Prior to Use 41 41
Malposition of Device 40 40
Fluid/Blood Leak 39 39
Retraction Problem 37 37
Device-Device Incompatibility 35 35
Insufficient Information 31 31
Device Contaminated During Manufacture or Shipping 26 26
Material Protrusion/Extrusion 25 25
Therapy Delivered to Incorrect Body Area 25 25
Device Contamination with Chemical or Other Material 24 24
Failure to Deflate 24 24
Difficult to Insert 21 21
Loss of or Failure to Bond 21 21
Device Markings/Labelling Problem 20 20
Device Damaged by Another Device 19 19
Partial Blockage 18 18
Material Fragmentation 17 17
Device Stenosis 16 16
No Apparent Adverse Event 15 15
Packaging Problem 15 15
Complete Blockage 15 15
Structural Problem 14 14
Problem with Sterilization 14 14
Unintended Movement 14 14
Material Perforation 12 12
Component Missing 12 12
Material Frayed 11 11
Activation Problem 11 11
Misfire 10 10
Mechanical Problem 9 9
Unraveled Material 9 9
Difficult to Open or Remove Packaging Material 7 7
Separation Failure 6 6
Product Quality Problem 6 6
Contamination 6 6
Peeled/Delaminated 5 5
Patient-Device Incompatibility 5 5
Patient Device Interaction Problem 5 5
Device Handling Problem 4 4
Poor Visibility 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Inadequacy of Device Shape and/or Size 4 4
Material Disintegration 4 4
Unintended Ejection 4 4
Calcified 3 3
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
Difficult to Open or Close 3 3
Gas/Air Leak 3 3
Human-Device Interface Problem 3 3
Infusion or Flow Problem 3 3
Contamination /Decontamination Problem 3 3
Separation Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5397 5397
No Consequences Or Impact To Patient 2786 2786
No Known Impact Or Consequence To Patient 800 800
Insufficient Information 221 221
Obstruction/Occlusion 200 200
Inflammation 159 159
Perforation 155 155
Foreign Body In Patient 147 147
Hemorrhage/Bleeding 114 114
No Patient Involvement 97 97
No Code Available 81 81
Pancreatitis 73 73
Pain 72 72
Occlusion 66 66
Device Embedded In Tissue or Plaque 62 62
Thrombosis/Thrombus 53 53
Stenosis 52 52
Abdominal Pain 49 49
Vascular Dissection 44 44
Restenosis 43 43
Unspecified Infection 41 41
Patient Problem/Medical Problem 40 40
Hematoma 36 36
Sepsis 35 35
Blood Loss 33 33
Fever 33 33
Abscess 31 31
Reocclusion 30 30
Failure of Implant 28 28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 27 27
Jaundice 26 26
Thrombosis 25 25
Injury 23 23
No Information 23 23
Pseudoaneurysm 21 21
Death 21 21
Peritonitis 20 20
Bowel Perforation 16 16
Ischemia 16 16
Renal Failure 15 15
Aneurysm 14 14
Embolism 13 13
Thrombus 13 13
Vomiting 13 13
Rupture 13 13
Discomfort 13 13
Perforation of Vessels 12 12
Embolism/Embolus 12 12
Fistula 12 12
Unspecified Tissue Injury 12 12
Stroke/CVA 11 11
Myocardial Infarction 10 10
Unspecified Hepatic or Biliary Problem 10 10
Swelling/ Edema 8 8
Low Blood Pressure/ Hypotension 8 8
Bacterial Infection 8 8
Erosion 8 8
Nausea 7 7
Pneumonia 7 7
Gastrointestinal Hemorrhage 7 7
Unintended Radiation Exposure 6 6
Laceration(s) 6 6
Hyperbilirubinemia 6 6
Arrhythmia 6 6
Cardiac Arrest 5 5
Hemoptysis 5 5
Internal Organ Perforation 5 5
Urinary Tract Infection 5 5
Septic Shock 5 5
Complaint, Ill-Defined 4 4
Claudication 4 4
Pleural Effusion 4 4
Chest Pain 4 4
Aspiration/Inhalation 4 4
Bradycardia 4 4
Intimal Dissection 4 4
Fluid Discharge 4 4
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
Diaphoresis 3 3
Aortic Dissection 3 3
Respiratory Insufficiency 3 3
Unspecified Vascular Problem 3 3
Shock 3 3
Great Vessel Perforation 3 3
Burning Sensation 2 2
Swelling 2 2
Vasoconstriction 2 2
Tissue Damage 2 2
Ulcer 2 2
Reaction 2 2
Dizziness 2 2
Heart Failure/Congestive Heart Failure 2 2
Abdominal Distention 2 2
Vascular System (Circulation), Impaired 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 Apr-12-2024
10 Cordis Corporation II Nov-12-2021
11 Cordis US Corp II Jul-11-2022
12 Hobbs Medical, Inc. II Oct-07-2022
13 Olympus Corporation of the Americas II Jan-31-2024
14 W.L. Gore & Associates, Inc. II Feb-22-2024
15 W.L. Gore & Associates, Inc. II May-14-2021
16 Wilson-Cook Medical Inc. II Dec-01-2023
-
-