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
  SUBSTANTIALLY EQUIVALENT 2
BRIGHTWATER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
COOK IRELAND
  SUBSTANTIALLY EQUIVALENT 1
COOK IRELAND LTD
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 2
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.
  SUBSTANTIALLY EQUIVALENT 1
GYRUS ACMI, INC.
  SUBSTANTIALLY EQUIVALENT 1
M.I.TECH CO., LTD.
  SE - WITH LIMITATIONS 2
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
TAEWOONG MEDICAL CO., LTD
  SE - WITH LIMITATIONS 2

MDR Year MDR Reports MDR Events
2018 1680 1680
2019 1895 1895
2020 2182 2182
2021 2302 2302
2022 1755 1755
2023 637 637

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 2288 2288
Break 982 982
Material Puncture/Hole 788 788
Adverse Event Without Identified Device or Use Problem 679 679
Improper or Incorrect Procedure or Method 672 672
Material Deformation 647 647
Burst Container or Vessel 585 585
Off-Label Use 487 487
Detachment of Device or Device Component 433 433
Difficult to Remove 386 386
Activation, Positioning or Separation Problem 380 380
Device Dislodged or Dislocated 341 341
Migration 302 302
Difficult to Advance 251 251
Fracture 250 250
Use of Device Problem 240 240
Positioning Failure 223 223
Leak/Splash 217 217
Activation Failure 204 204
Premature Activation 180 180
Material Twisted/Bent 172 172
Dent in Material 151 151
Inflation Problem 139 139
Migration or Expulsion of Device 128 128
Difficult or Delayed Positioning 127 127
Failure to Advance 125 125
Entrapment of Device 118 118
Obstruction of Flow 109 109
Material Integrity Problem 103 103
Positioning Problem 102 102
Deflation Problem 88 88
Material Separation 84 84
Physical Resistance/Sticking 64 64
Defective Device 59 59
Appropriate Term/Code Not Available 56 56
Crack 54 54
Kinked 52 52
Defective Component 49 49
Unintended Movement 48 48
Mechanical Jam 48 48
Malposition of Device 46 46
Device Damaged Prior to Use 45 45
Material Split, Cut or Torn 44 44
Difficult or Delayed Activation 43 43
Deformation Due to Compressive Stress 43 43
Tear, Rip or Hole in Device Packaging 42 42
Insufficient Information 40 40
Device Contamination with Chemical or Other Material 39 39
Stretched 37 37
Unsealed Device Packaging 36 36
Retraction Problem 34 34
Therapy Delivered to Incorrect Body Area 31 31
Device-Device Incompatibility 30 30
Partial Blockage 28 28
Detachment Of Device Component 27 27
Occlusion Within Device 26 26
Material Protrusion/Extrusion 25 25
Fluid/Blood Leak 24 24
Material Fragmentation 22 22
Device Contaminated During Manufacture or Shipping 20 20
Bent 19 19
Loss of or Failure to Bond 18 18
Delivery System Failure 17 17
Device Markings/Labelling Problem 17 17
Device Damaged by Another Device 16 16
Structural Problem 16 16
Packaging Problem 16 16
Calcified 16 16
Difficult to Insert 16 16
Complete Blockage 15 15
Problem with Sterilization 15 15
Material Perforation 15 15
Contamination /Decontamination Problem 15 15
No Apparent Adverse Event 14 14
Failure to Deflate 13 13
Component Missing 12 12
Material Frayed 12 12
Misfire 11 11
Activation Problem 10 10
Mechanical Problem 9 9
Unraveled Material 8 8
Hole In Material 8 8
Device Packaging Compromised 8 8
Device Stenosis 8 8
Separation Failure 7 7
Inaccurate Delivery 7 7
Difficult to Open or Remove Packaging Material 7 7
Contamination 7 7
Product Quality Problem 6 6
Difficult To Position 6 6
Human-Device Interface Problem 5 5
Device Operates Differently Than Expected 5 5
Patient-Device Incompatibility 5 5
Patient Device Interaction Problem 5 5
Separation Problem 5 5
Device Handling Problem 4 4
Device Difficult to Setup or Prepare 4 4
Material Disintegration 4 4
Unintended Ejection 4 4
Component Falling 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4202 4202
No Consequences Or Impact To Patient 3931 3931
No Known Impact Or Consequence To Patient 1011 1011
Insufficient Information 187 187
Inflammation 168 168
No Patient Involvement 164 164
Obstruction/Occlusion 164 164
Perforation 148 148
Foreign Body In Patient 141 141
Hemorrhage/Bleeding 117 117
No Code Available 104 104
Device Embedded In Tissue or Plaque 82 82
Occlusion 81 81
Patient Problem/Medical Problem 73 73
Pain 67 67
Stenosis 61 61
Pancreatitis 54 54
Thrombosis/Thrombus 53 53
Reocclusion 52 52
Abdominal Pain 48 48
Death 47 47
Vascular Dissection 46 46
Thrombosis 45 45
Restenosis 42 42
Unspecified Infection 41 41
Hematoma 38 38
Blood Loss 35 35
Fever 33 33
Failure of Implant 33 33
No Information 29 29
Sepsis 27 27
Jaundice 26 26
Injury 26 26
Abscess 25 25
Pseudoaneurysm 23 23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 23 23
Aneurysm 20 20
Peritonitis 19 19
Embolism 18 18
Ischemia 16 16
Thrombus 15 15
Bowel Perforation 15 15
Renal Failure 13 13
Rupture 13 13
Stroke/CVA 12 12
Perforation of Vessels 11 11
Embolism/Embolus 11 11
Unspecified Tissue Injury 10 10
Myocardial Infarction 10 10
Fistula 10 10
Bacterial Infection 9 9
Discomfort 9 9
Vomiting 8 8
Erosion 8 8
Low Blood Pressure/ Hypotension 8 8
Unspecified Hepatic or Biliary Problem 8 8
Swelling/ Edema 7 7
Vascular System (Circulation), Impaired 7 7
Claudication 6 6
Nausea 6 6
Laceration(s) 6 6
Arrhythmia 6 6
Intimal Dissection 5 5
Cardiac Arrest 5 5
Internal Organ Perforation 5 5
Pneumonia 5 5
Hypoxia 5 5
Septic Shock 5 5
Complaint, Ill-Defined 5 5
Cramp(s) 5 5
Gastrointestinal Hemorrhage 5 5
Unintended Radiation Exposure 4 4
Fluid Discharge 4 4
Hypersensitivity/Allergic reaction 4 4
Hemoptysis 4 4
Pleural Effusion 4 4
Necrosis 4 4
Chest Pain 4 4
Aspiration/Inhalation 4 4
Bradycardia 4 4
Vessel Or Plaque, Device Embedded In 3 3
Cellulitis 3 3
Purulent Discharge 3 3
Pneumothorax 3 3
High Blood Pressure/ Hypertension 3 3
Hyperbilirubinemia 3 3
Aortic Dissection 3 3
Thromboembolism 3 3
Reaction 3 3
Heart Failure 3 3
Vasoconstriction 3 3
Great Vessel Perforation 3 3
Rash 3 3
Shock 3 3
Tissue Damage 3 3
Respiratory Insufficiency 3 3
Unspecified Vascular Problem 3 3
Renal Impairment 2 2
Transient Ischemic Attack 2 2
Urinary Tract Infection 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 Medical Incorporated II Oct-31-2018
10 Cordis Corporation II Nov-12-2021
11 Cordis Corporation II Jan-09-2018
12 Cordis US Corp II Jul-11-2022
13 Hobbs Medical, Inc. II Oct-07-2022
14 W.L. Gore & Associates, Inc. II May-14-2021
-
-