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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
2018 396 396
2019 388 388
2020 364 364
2021 351 351
2022 274 274
2023 85 85

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 545 545
Burst Container or Vessel 473 473
Material Puncture/Hole 254 254
Fluid/Blood Leak 126 126
Deflation Problem 95 95
Fracture 80 80
Use of Device Problem 79 79
Leak/Splash 71 71
Crack 61 61
Detachment of Device or Device Component 55 55
Break 50 50
Material Twisted/Bent 42 42
Adverse Event Without Identified Device or Use Problem 37 37
Inflation Problem 33 33
Difficult to Remove 33 33
Off-Label Use 23 23
Material Deformation 21 21
Improper or Incorrect Procedure or Method 18 18
Material Fragmentation 18 18
Material Integrity Problem 11 11
Failure to Deflate 11 11
Contamination /Decontamination Problem 9 9
Delivered as Unsterile Product 9 9
Unsealed Device Packaging 8 8
Detachment Of Device Component 8 8
Appropriate Term/Code Not Available 8 8
Device-Device Incompatibility 7 7
Deformation Due to Compressive Stress 6 6
Tear, Rip or Hole in Device Packaging 6 6
Retraction Problem 6 6
Material Separation 5 5
Failure to Advance 5 5
Physical Resistance/Sticking 5 5
Packaging Problem 4 4
Defective Device 4 4
Difficult to Advance 4 4
Hole In Material 4 4
Entrapment of Device 4 4
Difficult to Insert 3 3
Shipping Damage or Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Material Split, Cut or Torn 3 3
Failure to Eject 3 3
Insufficient Information 2 2
No Pressure 2 2
Volume Accuracy Problem 2 2
Device Damaged Prior to Use 1 1
Incomplete or Missing Packaging 1 1
Unraveled Material 1 1
Product Quality Problem 1 1
Migration or Expulsion of Device 1 1
Contamination 1 1
Degraded 1 1
Bent 1 1
Complete Blockage 1 1
Output Problem 1 1
Mechanical Jam 1 1
Torn Material 1 1
Unintended Movement 1 1
Migration 1 1
Unintended Deflation 1 1
Device Fell 1 1
Human-Device Interface Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device Dislodged or Dislocated 1 1
Device Damaged by Another Device 1 1
Device Packaging Compromised 1 1
Obstruction of Flow 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 988 988
No Clinical Signs, Symptoms or Conditions 656 656
No Known Impact Or Consequence To Patient 103 103
No Patient Involvement 31 31
Insufficient Information 19 19
Foreign Body In Patient 18 18
Perforation 16 16
Device Embedded In Tissue or Plaque 13 13
Perforation of Esophagus 12 12
Laceration(s) of Esophagus 7 7
Hemorrhage/Bleeding 7 7
Chest Pain 4 4
Laceration(s) 4 4
Gastrointestinal Hemorrhage 4 4
No Code Available 3 3
Unspecified Tissue Injury 3 3
Aspiration/Inhalation 3 3
Death 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Pancreatitis 1 1
Obstruction/Occlusion 1 1
Needle Stick/Puncture 1 1
Patient Problem/Medical Problem 1 1
Fever 1 1
Fistula 1 1
Hemostasis 1 1
Intimal Dissection 1 1
Abdominal Pain 1 1
Abscess 1 1
Anxiety 1 1
Injury 1 1
Nerve Damage 1 1
Pain 1 1
Tissue Damage 1 1
Vomiting 1 1

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