• 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 prosthesis, esophageal
Regulation Description Esophageal prosthesis.
Product CodeESW
Regulation Number 878.3610
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
M.I. TECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
M.I.TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
TAEWOONG MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 87 87
2018 86 86
2019 169 169
2020 155 155
2021 77 77

Device Problems MDRs with this Device Problem Events in those MDRs
Activation, Positioning or SeparationProblem 159 159
Activation Failure 121 121
Activation Problem 59 59
Adverse Event Without Identified Device or Use Problem 58 58
Positioning Problem 57 57
Migration 51 51
Break 43 43
Migration or Expulsion of Device 43 43
Material Deformation 36 36
Use of Device Problem 29 29
Difficult to Remove 26 26
Appropriate Term/Code Not Available 22 22
Insufficient Information 21 21
Positioning Failure 21 21
Material Integrity Problem 20 20
Fracture 18 18
Failure to Advance 13 13
Detachment of Device or Device Component 13 13
Obstruction of Flow 9 9
Premature Activation 9 9
Physical Resistance/Sticking 8 8
Material Separation 7 7
Off-Label Use 6 6
Unraveled Material 5 5
Improper or Incorrect Procedure or Method 5 5
Difficult or Delayed Positioning 5 5
Device Markings/Labelling Problem 5 5
Material Twisted/Bent 5 5
Material Perforation 4 4
Component Missing 4 4
Structural Problem 4 4
Kinked 4 4
Delivery System Failure 3 3
Human-Device Interface Problem 3 3
Infusion or Flow Problem 3 3
Difficult to Advance 3 3
Sharp Edges 2 2
Material Split, Cut or Torn 2 2
Malposition of Device 2 2
Detachment Of Device Component 2 2
Partial Blockage 1 1
Loss of or Failure to Bond 1 1
Entrapment of Device 1 1
Material Erosion 1 1
Fluid Leak 1 1
Knotted 1 1
Leak/Splash 1 1
Unsealed Device Packaging 1 1
Patient-Device Incompatibility 1 1
Deformation Due to Compressive Stress 1 1
Separation Failure 1 1
Difficult or Delayed Activation 1 1
Defective Device 1 1
Device Or Device Fragments Location Unknown 1 1
Failure to Fire 1 1
Failure to Deliver 1 1
Tear, Rip or Hole in Device Packaging 1 1
Torn Material 1 1
Difficult to Open or Close 1 1
Human Factors Issue 1 1
Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 256 256
No Clinical Signs, Symptoms or Conditions 85 85
No Known Impact Or Consequence To Patient 67 67
No Code Available 43 43
Dysphagia/ Odynophagia 21 21
Hemorrhage/Bleeding 15 15
Obstruction/Occlusion 15 15
Pain 14 14
Erosion 14 14
Death 13 13
Fistula 10 10
Perforation 9 9
Failure of Implant 7 7
Occlusion 7 7
Vomiting 7 7
Blood Loss 7 7
No Information 7 7
Discomfort 6 6
Pneumonia 6 6
Chest Pain 6 6
Fever 5 5
Regurgitation 5 5
Insufficient Information 4 4
Foreign Body In Patient 3 3
Injury 3 3
Perforation of Esophagus 3 3
Dysphasia 3 3
Peritonitis 3 3
Nausea 3 3
Aspiration/Inhalation 3 3
Abdominal Pain 2 2
Excessive Tear Production 2 2
Difficulty Chewing 2 2
No Patient Involvement 1 1
Laceration(s) of Esophagus 1 1
Skin Tears 1 1
Device Embedded In Tissue or Plaque 1 1
Hernia 1 1
Radiation Underdose 1 1
Stenosis 1 1
Unspecified Infection 1 1
Pneumothorax 1 1
Pulmonary Dysfunction 1 1
Tissue Damage 1 1
Ulceration 1 1
Abrasion 1 1
Airway Obstruction 1 1
Host-Tissue Reaction 1 1
Dyspnea 1 1
Erythema 1 1
Exsanguination 1 1
Foreign Body Reaction 1 1
Gastritis 1 1
Pyrosis/Heartburn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Taewoong Medical Co., Ltd. II Feb-14-2020
-
-