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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dilator, esophageal
Regulation Description Esophageal dilator.
Product CodeKNQ
Regulation Number 876.5365
Device Class 2

MDR Year MDR Reports MDR Events
2016 153 163
2017 231 231
2018 396 396
2019 388 388
2020 364 364
2021 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 477 477
Balloon 315 315
Burst Container or Vessel 307 309
Material Puncture/Hole 150 150
Use of Device Problem 125 132
Deflation Problem 102 102
Crack 95 101
Fluid Leak 77 77
Leak/Splash 77 77
Hole In Material 60 62
Detachment Of Device Component 48 48
Catheter 47 47
Break 41 41
Device Subassembly 36 36
Detachment of Device or Device Component 34 34
Material Twisted/Bent 33 33
Material Deformation 33 33
Difficult to Remove 30 30
Off-Label Use 27 27
Improper or Incorrect Procedure or Method 27 27
Fracture 26 26
Adverse Event Without Identified Device or Use Problem 24 24
Inflation Problem 19 19
Material Fragmentation 17 17
Tear, Rip or Hole in Device Packaging 17 17
Tip 16 16
Bent 13 13
Delivered as Unsterile Product 10 10
Contamination /Decontamination Problem 10 10
Unsealed Device Packaging 8 8
Appropriate Term/Code Not Available 8 8
Material Separation 7 7
Material Integrity Problem 7 7
Shaft 7 7
Device-Device Incompatibility 6 6
Retraction Problem 6 6
Device Operates Differently Than Expected 4 4
Physical Resistance/Sticking 4 4
Kinked 4 4
Entrapment of Device 4 4
Guidewire 4 4
Device Damaged by Another Device 3 3
Defective Device 3 3
Device Dislodged or Dislocated 3 3
Material Perforation 3 3
Material Split, Cut or Torn 3 3
Failure to Eject 3 3
Packaging Problem 3 3
Torn Material 3 3
Insufficient Information 2 2
Component Missing 2 2
Migration or Expulsion of Device 2 2
Spring 2 2
Difficult to Insert 2 2
Failure to Advance 2 2
Device Damaged Prior to Use 2 2
Volume Accuracy Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Device Contaminated During Manufacture or Shipping 1 1
Difficult to Advance 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Pressure Problem 1 1
Unintended Movement 1 1
Migration 1 1
Sticking 1 1
Device Inoperable 1 1
Unraveled Material 1 1
Product Quality Problem 1 1
Complete Blockage 1 1
Loss of or Failure to Bond 1 1
Cap 1 1
Seal 1 1
Degraded 1 1
Obstruction of Flow 1 1
Failure to Cut 1 1
Human-Device Interface Problem 1 1
Improper Flow or Infusion 1 1
Deformation Due to Compressive Stress 1 1
Device Packaging Compromised 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1299 1309
No Known Impact Or Consequence To Patient 130 130
No Patient Involvement 45 45
No Clinical Signs, Symptoms or Conditions 23 23
Device Embedded In Tissue or Plaque 19 19
Foreign Body In Patient 19 19
Perforation 19 19
Perforation of Esophagus 10 10
Laceration(s) of Esophagus 9 9
No Code Available 7 7
Aspiration/Inhalation 5 5
Chest Pain 4 4
Hemorrhage/Bleeding 4 4
Laceration(s) 4 4
No Information 4 4
Tissue Damage 3 3
Death 3 3
Injury 3 3
Intimal Dissection 2 2
Blood Loss 2 2
Bowel Perforation 1 1
Hemostasis 1 1
Hypoxia 1 1
Nerve Damage 1 1
Patient Problem/Medical Problem 1 1

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