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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


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
COOK ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 1
ETHICON ENDO-SURGERY, INC.
  SUBSTANTIALLY EQUIVALENT 1
SAFESTITCH MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 164 164
2015 204 204
2016 154 164
2017 231 231
2018 396 396
2019 388 388
2020 364 364
2021 351 351
2022 274 274
2023 319 319
2024 92 92

Device Problems MDRs with this Device Problem Events in those MDRs
Burst Container or Vessel 715 717
Material Rupture 678 678
Material Puncture/Hole 287 287
Deflation Problem 203 203
Use of Device Problem 189 196
Fluid/Blood Leak 149 149
Leak/Splash 136 136
Fracture 122 122
Hole In Material 118 120
Crack 116 122
Break 81 81
Detachment Of Device Component 76 76
Adverse Event Without Identified Device or Use Problem 69 69
Difficult to Remove 66 66
Detachment of Device or Device Component 64 64
Material Deformation 59 59
Inflation Problem 51 51
Material Twisted/Bent 44 44
Off-Label Use 43 43
Failure to Deflate 43 43
Improper or Incorrect Procedure or Method 36 36
Material Fragmentation 34 34
Bent 25 25
Material Integrity Problem 18 18
Tear, Rip or Hole in Device Packaging 17 17
Material Separation 17 17
Contamination /Decontamination Problem 10 10
Delivered as Unsterile Product 10 10
Torn Material 9 9
Unsealed Device Packaging 8 8
Appropriate Term/Code Not Available 8 8
Deformation Due to Compressive Stress 7 7
Physical Resistance/Sticking 7 7
Device-Device Incompatibility 7 7
Entrapment of Device 7 7
Difficult to Advance 6 6
Retraction Problem 6 6
Failure to Advance 5 5
Device Operates Differently Than Expected 5 5
Kinked 5 5
Insufficient Information 4 4
Defective Device 4 4
Material Perforation 4 4
Packaging Problem 4 4
Device Damaged by Another Device 4 4
Device Packaging Compromised 4 4
Device Dislodged or Dislocated 4 4
Material Split, Cut or Torn 4 4
Shipping Damage or Problem 3 3
Failure to Eject 3 3
Gas/Air Leak 3 3
Device Contamination with Chemical or Other Material 3 3
Mechanical Problem 3 3
Difficult to Insert 3 3
Device Damaged Prior to Use 2 2
Volume Accuracy Problem 2 2
Device Markings/Labelling Problem 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Accessory Incompatible 2 2
Sticking 2 2
No Pressure 2 2
Mechanical Jam 2 2
Migration or Expulsion of Device 2 2
Contamination 2 2
Component Missing 2 2
Failure to Cut 1 1
Degraded 1 1
Unintended Deflation 1 1
Loss of or Failure to Bond 1 1
Obstruction of Flow 1 1
Connection Problem 1 1
Unraveled Material 1 1
Device Fell 1 1
Defective Component 1 1
Device Inoperable 1 1
Product Quality Problem 1 1
Migration 1 1
Infusion or Flow Problem 1 1
Physical Resistance 1 1
Human-Device Interface Problem 1 1
Complete Blockage 1 1
Device Issue 1 1
Incomplete or Missing Packaging 1 1
Device Contaminated During Manufacture or Shipping 1 1
Unintended Movement 1 1
Pressure Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Malposition of Device 1 1
Improper Flow or Infusion 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1608 1618
No Clinical Signs, Symptoms or Conditions 967 967
No Known Impact Or Consequence To Patient 166 166
No Patient Involvement 48 48
Foreign Body In Patient 47 47
Device Embedded In Tissue or Plaque 27 27
Perforation 27 27
Insufficient Information 22 22
Perforation of Esophagus 18 18
Laceration(s) of Esophagus 14 14
No Information 11 11
Hemorrhage/Bleeding 11 11
No Code Available 8 8
Aspiration/Inhalation 6 6
Gastrointestinal Hemorrhage 6 6
Chest Pain 4 4
Tissue Damage 4 4
Laceration(s) 4 4
Injury 4 4
Death 3 3
Unspecified Tissue Injury 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Intimal Dissection 2 2
Abdominal Pain 2 2
Low Oxygen Saturation 2 2
Blood Loss 2 2
Cough 2 2
Patient Problem/Medical Problem 1 1
Bowel Perforation 1 1
Obstruction/Occlusion 1 1
Needle Stick/Puncture 1 1
Anxiety 1 1
Discomfort 1 1
Abscess 1 1
Nerve Damage 1 1
Pain 1 1
Perforation of Vessels 1 1
Vomiting 1 1
Pneumothorax 1 1
Fever 1 1
Fistula 1 1
Hemostasis 1 1
Hypoxia 1 1
Inflammation 1 1
Pancreatitis 1 1
Unspecified Gastrointestinal Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation III Jul-10-2013
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