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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dilator, esophageal
Product CodeKNQ
Regulation Number 876.5365
Device Class 2

MDR Year MDR Reports MDR Events
2019 388 388
2020 364 364
2021 351 351
2022 274 274
2023 319 319
2024 128 128

Device Problems MDRs with this Device Problem Events in those MDRs
Burst Container or Vessel 486 486
Material Rupture 429 429
Material Puncture/Hole 261 261
Fluid/Blood Leak 146 146
Fracture 122 122
Deflation Problem 94 94
Adverse Event Without Identified Device or Use Problem 60 60
Leak/Splash 57 57
Use of Device Problem 48 48
Detachment of Device or Device Component 47 47
Break 47 47
Failure to Deflate 46 46
Inflation Problem 42 42
Difficult to Remove 39 39
Material Twisted/Bent 38 38
Crack 25 25
Off-Label Use 22 22
Material Fragmentation 15 15
Material Integrity Problem 15 15
Material Deformation 14 14
Improper or Incorrect Procedure or Method 13 13
Appropriate Term/Code Not Available 8 8
Physical Resistance/Sticking 7 7
Device-Device Incompatibility 6 6
Difficult to Advance 6 6
Retraction Problem 6 6
Deformation Due to Compressive Stress 6 6
Failure to Advance 5 5
Material Split, Cut or Torn 4 4
Entrapment of Device 4 4
Difficult to Insert 3 3
Packaging Problem 3 3
Mechanical Problem 3 3
Defective Device 3 3
Device Contamination with Chemical or Other Material 3 3
Material Separation 3 3
Shipping Damage or Problem 3 3
Failure to Eject 3 3
Tear, Rip or Hole in Device Packaging 3 3
Gas/Air Leak 3 3
Contamination 2 2
No Pressure 2 2
Accessory Incompatible 2 2
Device Misassembled During Manufacturing /Shipping 1 1
Device Contaminated During Manufacture or Shipping 1 1
Unintended Movement 1 1
Incomplete or Missing Packaging 1 1
Complete Blockage 1 1
Mechanical Jam 1 1
Device Damaged by Another Device 1 1
Unsealed Device Packaging 1 1
Material Perforation 1 1
Insufficient Information 1 1
Output Problem 1 1
Device Damaged Prior to Use 1 1
Device Fell 1 1
Migration 1 1
Migration or Expulsion of Device 1 1
Infusion or Flow Problem 1 1
Human-Device Interface Problem 1 1
Degraded 1 1
Unintended Deflation 1 1
Device Dislodged or Dislocated 1 1
Obstruction of Flow 1 1
Connection Problem 1 1
Unraveled Material 1 1
Contamination /Decontamination Problem 1 1
Delivered as Unsterile Product 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1002 1002
No Consequences Or Impact To Patient 646 646
No Known Impact Or Consequence To Patient 69 69
Insufficient Information 22 22
No Patient Involvement 20 20
Foreign Body In Patient 18 18
Perforation of Esophagus 13 13
Perforation 12 12
Laceration(s) of Esophagus 9 9
Device Embedded In Tissue or Plaque 9 9
Hemorrhage/Bleeding 8 8
Gastrointestinal Hemorrhage 6 6
Chest Pain 4 4
Death 3 3
Aspiration/Inhalation 3 3
Laceration(s) 3 3
Unspecified Tissue Injury 3 3
Low Oxygen Saturation 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Code Available 2 2
Cough 2 2
Obstruction/Occlusion 1 1
Needle Stick/Puncture 1 1
Patient Problem/Medical Problem 1 1
Pancreatitis 1 1
Unspecified Gastrointestinal Problem 1 1
Nerve Damage 1 1
Pain 1 1
Tissue Damage 1 1
Vomiting 1 1
Anxiety 1 1
Injury 1 1
Fever 1 1
Fistula 1 1
Hemostasis 1 1
Inflammation 1 1
Abdominal Pain 1 1
Abscess 1 1

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