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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

Device Problems
Material Rupture 356
Balloon 322
Burst Container or Vessel 274
Use of Device Problem 146
Crack 104
Deflation Problem 89
Hole In Material 82
Material Puncture / Hole 77
Leak / Splash 73
Detachment Of Device Component 59
Catheter 53
Device Subassembly 46
Fluid Leak 44
Material Deformation 32
Break 28
Difficult to Remove 27
Detachment of Device or device Component 26
Improper or Incorrect Procedure or Method 24
Off-Label Use 22
Adverse Event Without Identified Device or Use Problem 22
Material Fragmentation 17
Material Twisted / Bent 16
Tear, Rip or Hole in Device Packaging 16
Bent 14
Tip 12
Material Separation 12
Delivered as Unsterile Product 9
Contamination / decontamination Problem 9
Unsealed Device Packaging 8
Shaft 8
Retraction Problem 5
Device-Device Incompatibility 5
Physical Resistance / Sticking 4
Kinked 4
Fracture 4
Inflation Problem 4
Material Integrity Problem 4
Failure to Eject 3
Torn Material 3
Device Operates Differently Than Expected 3
Device Damaged by Another Device 3
Packaging Problem 3
Entrapment of Device 3
Material Perforation 2
Material Split, Cut or Torn 2
Device Markings / Labelling Problem 2
Insufficient Information 2
Volume Accuracy Problem 2
Guidewire 1
Unraveled Material 1
Device Dislodged or Dislocated 1
Product Quality Problem 1
Unintended Movement 1
Device Contamination with Chemical or Other Material 1
Deformation Due to Compressive Stress 1
Loss of or Failure to Bond 1
Manufacturing, Packaging or Shipping Problem 1
Difficult to Insert 1
Device Damaged Prior to Use 1
Seal 1
Device Misassembled During Manufacturing / Shipping 1
Device Packaging Compromised 1
Pressure Problem 1
Migration 1
Total Device Problems 2101


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