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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, thermal ablation, endometrial
Product CodeMNB
Device Class 3

Premarket Approvals (PMA)
2016 2017 2018 2019 2020 2021
5 8 9 8 19 21

MDR Year MDR Reports MDR Events
2016 295 295
2017 292 292
2018 262 262
2019 248 248
2020 197 197
2021 172 172

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 739 739
Insufficient Information 168 168
Device Operates Differently Than Expected 89 89
Fluid Leak 74 74
Device Displays Incorrect Message 63 63
Appropriate Term/Code Not Available 52 52
Device Alarm System 34 34
Material Puncture/Hole 31 31
Therapeutic or Diagnostic Output Failure 24 24
Defective Device 21 21
Material Deformation 21 21
Break 19 19
Device Inoperable 14 14
Use of Device Problem 10 10
Retraction Problem 10 10
Improper or Incorrect Procedure or Method 10 10
Loss of Power 9 9
Positioning Problem 9 9
Material Integrity Problem 8 8
Failure to Power Up 8 8
Defective Component 8 8
Leak/Splash 8 8
Device Contamination with Chemical or Other Material 7 7
Patient-Device Incompatibility 6 6
Difficult to Open or Close 6 6
Output Problem 6 6
Material Split, Cut or Torn 5 5
Smoking 5 5
Suction Problem 4 4
Failure to Fire 4 4
Failure to Advance 4 4
Failure to Calibrate 4 4
Melted 4 4
Electrical /Electronic Property Problem 4 4
Hole In Material 4 4
Detachment Of Device Component 4 4
Noise, Audible 4 4
Protective Measures Problem 4 4
Temperature Problem 4 4
Computer Operating System Problem 4 4
Activation, Positioning or SeparationProblem 4 4
Power Problem 3 3
Failure of Device to Self-Test 3 3
Crack 3 3
Positioning Failure 3 3
Backflow 3 3
Material Fragmentation 3 3
Display or Visual Feedback Problem 3 3
Mechanical Problem 3 3
Difficult To Position 3 3
Overheating of Device 2 2
Self-Activation or Keying 2 2
Material Separation 2 2
Unable to Obtain Readings 2 2
Difficult to Remove 2 2
Incorrect Or Inadequate Test Results 2 2
Malposition of Device 2 2
Fitting Problem 2 2
Material Perforation 2 2
No Display/Image 2 2
Deflation Problem 2 2
Difficult or Delayed Positioning 2 2
Material Twisted/Bent 2 2
Application Program Problem 2 2
No Apparent Adverse Event 2 2
Activation Failure 2 2
Suction Failure 2 2
Activation Problem 2 2
Unexpected Shutdown 1 1
Device Handling Problem 1 1
Unintended Movement 1 1
Deformation Due to Compressive Stress 1 1
Calibration Problem 1 1
Detachment of Device or Device Component 1 1
Connection Problem 1 1
Human Factors Issue 1 1
Human-Device Interface Problem 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Inadequate User Interface 1 1
Inappropriate or Unexpected Reset 1 1
Installation-Related Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Measurement System Incompatibility 1 1
Mechanical Jam 1 1
Mechanics Altered 1 1
Failure to Shut Off 1 1
Material Protrusion/Extrusion 1 1
Device Dislodged or Dislocated 1 1
Device Operational Issue 1 1
Difficult to Advance 1 1
Failure to Cycle 1 1
Component Falling 1 1
Insufficient Cooling 1 1
Air Leak 1 1
Bent 1 1
Thermal Decomposition of Device 1 1
Calibration Error 1 1
Charred 1 1
Material Frayed 1 1
Gel Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Uterine Perforation 372 372
No Known Impact Or Consequence To Patient 139 139
No Consequences Or Impact To Patient 135 135
Pain 132 132
Perforation 129 129
Burn(s) 112 112
Unspecified Infection 86 86
Bowel Burn 72 72
Abdominal Pain 69 69
Burn, Thermal 58 58
No Code Available 47 47
No Clinical Signs, Symptoms or Conditions 46 46
Hemorrhage/Bleeding 40 41
Bowel Perforation 39 39
Fever 33 33
Sepsis 24 24
Insufficient Information 19 19
No Information 16 16
Injury 16 16
Cramp(s) 13 13
Bacterial Infection 12 12
Abscess 12 12
Bradycardia 11 11
Inflammation 11 11
Cardiac Arrest 10 10
Complaint, Ill-Defined 10 10
Blood Loss 9 9
Nausea 9 9
Tissue Damage 8 8
Abdominal Cramps 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
No Patient Involvement 8 8
Intermenstrual Bleeding 7 7
Foreign Body In Patient 7 7
Vomiting 7 7
Menstrual Irregularities 7 7
Low Blood Pressure/ Hypotension 6 6
Swelling 6 6
Full thickness (Third Degree) Burn 6 6
Discomfort 6 6
Not Applicable 5 5
Heavier Menses 5 5
Vaso-Vagal Response 5 5
Scar Tissue 5 5
Hematoma 5 5
Adhesion(s) 5 5
Emotional Changes 4 4
Death 4 4
Urinary Tract Infection 4 4
Laceration(s) 4 4
Weight Changes 4 4
Test Result 4 4
Premature Menopause 4 4
Urinary Frequency 4 4
Peritonitis 3 3
Chills 3 3
Ambulation Difficulties 3 3
Constipation 3 3
Pregnancy 3 3
Device Embedded In Tissue or Plaque 3 3
Patient Problem/Medical Problem 3 3
Superficial (First Degree) Burn 3 3
Necrosis 3 3
Abnormal Vaginal Discharge 3 3
Scarring 3 3
Diarrhea 3 3
Purulent Discharge 3 3
Cyst(s) 3 3
Headache 3 3
Fistula 2 2
Fatigue 2 2
Air Embolism 2 2
Anemia 2 3
Pulmonary Embolism 2 2
Respiratory Distress 2 2
Hot Flashes/Flushes 2 2
Dizziness 2 2
Internal Organ Perforation 2 2
Pelvic Inflammatory Disease 2 2
Infiltration into Tissue 2 2
Irritation 2 2
Dysuria 2 2
Unspecified Tissue Injury 2 2
Abdominal Distention 2 2
Sleep Dysfunction 2 2
Sweating 2 2
Depression 2 2
Therapeutic Response, Decreased 2 2
Anxiety 1 1
Discharge 1 1
Excessive Tear Production 1 1
Myalgia 1 1
Impaired Healing 1 1
Inadequate Pain Relief 1 1
Obstruction/Occlusion 1 1
Tooth Fracture 1 1
Skin Inflammation 1 1
Joint Swelling 1 1
Malaise 1 1
Post Operative Wound Infection 1 1

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