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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
2019 294 294
2020 345 345
2021 674 674
2022 808 808
2023 689 689
2024 351 351

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Fire 2083 2083
Premature Activation 391 391
Use of Device Problem 307 307
Break 304 304
Material Integrity Problem 157 157
Detachment of Device or Device Component 122 122
Human-Device Interface Problem 87 87
Device Dislodged or Dislocated 80 80
Defective Device 60 60
Difficult or Delayed Positioning 58 58
Device Difficult to Setup or Prepare 55 55
Adverse Event Without Identified Device or Use Problem 42 42
Material Too Soft/Flexible 42 42
Difficult to Remove 40 40
Misfire 39 39
Material Separation 36 36
Premature Separation 35 35
Material Deformation 28 28
Activation, Positioning or Separation Problem 26 26
Entrapment of Device 23 23
Unintended Movement 19 19
Misassembly by Users 16 16
Difficult or Delayed Separation 15 15
Device-Device Incompatibility 15 15
Positioning Failure 10 10
Suction Problem 10 10
Separation Failure 7 7
Off-Label Use 7 7
Device Misassembled During Manufacturing /Shipping 7 7
Device Handling Problem 7 7
Material Twisted/Bent 6 6
Improper or Incorrect Procedure or Method 6 6
Fracture 6 6
Degraded 6 6
Mechanical Problem 5 5
Physical Resistance/Sticking 5 5
Activation Problem 4 4
Appropriate Term/Code Not Available 4 4
Migration 4 4
Inability to Irrigate 4 4
Component Missing 4 4
Shipping Damage or Problem 3 3
Misassembled 3 3
Unsealed Device Packaging 3 3
Accessory Incompatible 3 3
Activation Failure 3 3
Insufficient Information 3 3
Separation Problem 3 3
Device Fell 3 3
Mechanical Jam 3 3
Malposition of Device 3 3
Therapeutic or Diagnostic Output Failure 2 2
Material Split, Cut or Torn 2 2
Nonstandard Device 2 2
Retraction Problem 2 2
Product Quality Problem 1 1
Failure to Disconnect 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Premature Discharge of Battery 1 1
Partial Blockage 1 1
Contamination 1 1
Fluid/Blood Leak 1 1
Firing Problem 1 1
Failure to Clean Adequately 1 1
Packaging Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Contamination /Decontamination Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Gas/Air Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2409 2409
No Consequences Or Impact To Patient 518 518
Hemorrhage/Bleeding 94 94
No Known Impact Or Consequence To Patient 85 85
Foreign Body In Patient 49 49
No Patient Involvement 48 48
Insufficient Information 30 30
Gastrointestinal Hemorrhage 28 28
Perforation 7 7
No Code Available 6 6
Peritonitis 6 6
Low Oxygen Saturation 3 3
Unspecified Tissue Injury 3 3
Swelling/ Edema 3 3
Hemostasis 3 3
Low Blood Pressure/ Hypotension 3 3
Abdominal Pain 3 3
Fever 3 3
Bradycardia 2 2
Dysphagia/ Odynophagia 2 2
Laceration(s) 2 2
Laceration(s) of Esophagus 2 2
Obstruction/Occlusion 1 1
Blood Loss 1 1
Distress 1 1
Malaise 1 1
Hypovolemia 1 1
Stenosis of the esophagus 1 1
Ischemia Stroke 1 1
Bowel Perforation 1 1
Tissue Damage 1 1
Hypoxia 1 1
Inflammation 1 1
Cardiopulmonary Arrest 1 1
Chest Pain 1 1
Death 1 1
Foreign Body Reaction 1 1
Aspiration/Inhalation 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Micro-Tech Usa II Nov-18-2020
2 Olympus Corporation of the Americas II Apr-20-2023
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