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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
  1.  K090183  HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON
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 109 109

Device Problems MDRs with this Device Problem Events in those MDRs
Burst Container or Vessel 721 723
Material Rupture 682 682
Material Puncture/Hole 289 289
Deflation Problem 203 203
Use of Device Problem 190 197
Fluid/Blood Leak 151 151
Leak/Splash 137 137
Fracture 123 123
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 71 71
Difficult to Remove 66 66
Detachment of Device or Device Component 64 64
Material Deformation 59 59
Inflation Problem 51 51
Failure to Deflate 45 45
Material Twisted/Bent 44 44
Off-Label Use 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
Delivered as Unsterile Product 10 10
Contamination /Decontamination Problem 10 10
Torn Material 9 9
Appropriate Term/Code Not Available 8 8
Device-Device Incompatibility 8 8
Unsealed Device Packaging 8 8
Entrapment of Device 7 7
Deformation Due to Compressive Stress 7 7
Physical Resistance/Sticking 7 7
Retraction Problem 6 6
Difficult to Advance 6 6
Failure to Advance 6 6
Device Operates Differently Than Expected 5 5
Kinked 5 5
Device Damaged by Another Device 4 4
Device Packaging Compromised 4 4
Device Dislodged or Dislocated 4 4
Defective Device 4 4
Material Perforation 4 4
Material Split, Cut or Torn 4 4
Insufficient Information 4 4
Packaging Problem 4 4
Failure to Eject 3 3
Device Contamination with Chemical or Other Material 3 3
Gas/Air Leak 3 3
Mechanical Problem 3 3
Shipping Damage or Problem 3 3
Difficult to Insert 3 3
Accessory Incompatible 2 2
Contamination 2 2
Sticking 2 2
Volume Accuracy Problem 2 2
Migration or Expulsion of Device 2 2
Mechanical Jam 2 2
No Pressure 2 2
Device Damaged Prior to Use 2 2
Component Missing 2 2
Device Markings/Labelling Problem 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Connection Problem 1 1
Malposition of Device 1 1
Physical Resistance 1 1
Failure to Cut 1 1
Incomplete or Missing Packaging 1 1
Device Issue 1 1
Obstruction of Flow 1 1
Defective Component 1 1
Output Problem 1 1
Human-Device Interface Problem 1 1
Improper Flow or Infusion 1 1
Infusion or Flow Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Product Quality Problem 1 1
Device Inoperable 1 1
Unraveled Material 1 1
Complete Blockage 1 1
Loss of or Failure to Bond 1 1
Degraded 1 1
Device Fell 1 1
Unintended Deflation 1 1
Pressure Problem 1 1
Unintended Movement 1 1
Migration 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 984 984
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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