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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ligator, esophageal
Product CodeMND
Regulation Number 876.4400
Device Class 2

MDR Year MDR Reports MDR Events
2017 88 88
2018 124 124
2019 294 294
2020 345 345
2021 674 674
2022 569 569

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Fire 1288 1288
Premature Activation 294 294
Use of Device Problem 207 207
Break 177 177
Material Integrity Problem 95 95
Detachment of Device or Device Component 89 89
Defective Device 57 57
Human-Device Interface Problem 51 51
Device Dislodged or Dislocated 47 47
Difficult or Delayed Positioning 47 47
Premature Separation 39 39
Positioning Failure 36 36
Device Difficult to Setup or Prepare 32 32
Material Separation 31 31
Adverse Event Without Identified Device or Use Problem 28 28
Activation, Positioning or SeparationProblem 26 26
Entrapment of Device 26 26
Misfire 25 25
Material Too Soft/Flexible 25 25
Improper or Incorrect Procedure or Method 21 21
Device-Device Incompatibility 18 18
Device Operates Differently Than Expected 17 17
Difficult or Delayed Separation 16 16
Misassembly by Users 15 15
Detachment Of Device Component 15 15
Difficult to Remove 13 13
Compatibility Problem 13 13
Material Deformation 12 12
Migration or Expulsion of Device 12 12
Unintended Movement 10 10
Degraded 8 8
Fracture 7 7
Separation Failure 7 7
Device Misassembled During Manufacturing /Shipping 7 7
Device Handling Problem 6 6
Shelf Life Exceeded 5 5
Suction Problem 5 5
Inability to Irrigate 4 4
Activation Problem 4 4
Migration 4 4
Appropriate Term/Code Not Available 4 4
Material Twisted/Bent 4 4
Mechanical Jam 2 2
Therapeutic or Diagnostic Output Failure 2 2
Device Fell 2 2
Activation Failure 2 2
Mechanical Problem 2 2
Unsealed Device Packaging 2 2
Off-Label Use 2 2
Shipping Damage or Problem 2 2
Contamination /Decontamination Problem 1 1
Retraction Problem 1 1
Component Missing 1 1
Device Issue 1 1
Tear, Rip or Hole in Device Packaging 1 1
Difficult To Position 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Contamination 1 1
Accessory Incompatible 1 1
Premature Discharge of Battery 1 1
Partial Blockage 1 1
Fluid Leak 1 1
Firing Problem 1 1
Physical Resistance/Sticking 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device Contamination with Chemical or Other Material 1 1
Gas Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1189 1189
No Consequences Or Impact To Patient 664 664
No Known Impact Or Consequence To Patient 98 98
No Patient Involvement 82 82
Hemorrhage/Bleeding 80 80
Foreign Body In Patient 76 76
Insufficient Information 26 26
Gastrointestinal Hemorrhage 16 16
No Code Available 6 6
Hemostasis 6 6
Death 4 4
Peritonitis 4 4
Low Blood Pressure/ Hypotension 3 3
Laceration(s) 2 2
Perforation 2 2
Bradycardia 2 2
Cardiopulmonary Arrest 1 1
Chest Pain 1 1
Dysphagia/ Odynophagia 1 1
Foreign Body Reaction 1 1
Respiratory Distress 1 1
Tissue Damage 1 1
Laceration(s) of Esophagus 1 1
Blood Loss 1 1
Hypovolemia 1 1
No Information 1 1
Ischemia Stroke 1 1
Stenosis of the esophagus 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Airway Obstruction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Micro-Tech Usa II Nov-18-2020
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