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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 371
Balloon 323
Burst Container or Vessel 280
Use of Device Problem 146
Crack 105
Deflation Problem 93
Material Puncture / Hole 89
Hole In Material 82
Leak / Splash 73
Detachment Of Device Component 59
Catheter 53
Fluid Leak 50
Device Subassembly 46
Material Deformation 33
Break 30
Difficult to Remove 28
Detachment of Device or device Component 27
Improper or Incorrect Procedure or Method 25
Off-Label Use 23
Adverse Event Without Identified Device or Use Problem 22
Material Twisted / Bent 19
Material Fragmentation 17
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
Fracture 6
Device-Device Incompatibility 5
Material Integrity Problem 5
Retraction Problem 5
Inflation Problem 4
Physical Resistance / Sticking 4
Kinked 4
Entrapment of Device 3
Failure to Eject 3
Torn Material 3
Device Operates Differently Than Expected 3
Device Damaged by Another Device 3
Packaging Problem 3
Insufficient Information 2
Volume Accuracy Problem 2
Material Perforation 2
Material Split, Cut or Torn 2
Device Markings / Labelling Problem 2
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
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
Total Device Problems 2159


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