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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)
2020 2021 2022 2023 2024 2025
19 22 9 16 13 1

MDR Year MDR Reports MDR Events
2020 197 197
2021 229 229
2022 179 179
2023 213 213
2024 213 213

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 517 517
Material Puncture/Hole 119 119
Use of Device Problem 55 55
Material Deformation 29 29
Appropriate Term/Code Not Available 29 29
Therapeutic or Diagnostic Output Failure 25 25
Detachment of Device or Device Component 23 23
Device Displays Incorrect Message 23 23
Insufficient Information 22 22
Material Split, Cut or Torn 18 18
Defective Device 17 17
Mechanical Problem 12 12
Protective Measures Problem 8 8
Output Problem 8 8
Fluid/Blood Leak 8 8
Improper or Incorrect Procedure or Method 8 8
Device Alarm System 7 7
Material Twisted/Bent 6 6
Melted 6 6
No Apparent Adverse Event 5 5
Energy Output Problem 5 5
Temperature Problem 5 5
Suction Failure 4 4
Difficult to Open or Close 4 4
Break 4 4
Power Problem 4 4
Activation Failure 4 4
Leak/Splash 4 4
Patient-Device Incompatibility 3 3
Material Integrity Problem 3 3
Off-Label Use 3 3
Material Separation 3 3
Collapse 2 2
Crack 2 2
Defective Component 2 2
Activation Problem 2 2
Display or Visual Feedback Problem 2 2
Malposition of Device 2 2
Material Fragmentation 2 2
Unable to Obtain Readings 2 2
Device Contamination with Body Fluid 2 2
Failure to Power Up 2 2
Unexpected Shutdown 2 2
Electrical Shorting 2 2
Deformation Due to Compressive Stress 1 1
Mechanical Jam 1 1
Self-Activation or Keying 1 1
Insufficient Cooling 1 1
Suction Problem 1 1
Excessive Heating 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Uterine Perforation 311 311
No Clinical Signs, Symptoms or Conditions 287 287
Bowel Burn 74 74
Insufficient Information 53 53
Pain 51 51
Foreign Body In Patient 39 39
Burn(s) 36 36
Abdominal Pain 33 33
No Known Impact Or Consequence To Patient 30 30
Bowel Perforation 28 28
No Consequences Or Impact To Patient 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 17 17
Unspecified Infection 17 17
Hemorrhage/Bleeding 16 16
Intermenstrual Bleeding 16 16
Sepsis 13 13
Bradycardia 12 12
Fever 11 11
Bacterial Infection 10 10
Cardiac Arrest 9 9
Partial thickness (Second Degree) Burn 8 8
Burn, Thermal 8 8
Abscess 7 7
Superficial (First Degree) Burn 7 7
Cramp(s) /Muscle Spasm(s) 7 7
Perforation 6 6
Vomiting 5 5
Necrosis 5 5
Nausea 5 5
Hematoma 4 4
Premature Menopause 4 4
Pelvic Inflammatory Disease 4 4
No Code Available 4 4
Discomfort 4 4
Abdominal Cramps 3 3
Abnormal Vaginal Discharge 3 3
Full thickness (Third Degree) Burn 3 3
Cervical Changes 3 3
Menstrual Irregularities 3 3
Unspecified Tissue Injury 3 3
Blood Loss 2 2
Fibrosis 2 2
Peritonitis 2 2
Urinary Incontinence 2 2
Electric Shock 2 2
Weight Changes 2 2
Tissue Damage 2 2
Scar Tissue 2 2
Laceration(s) 2 2
Nodule 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Channel Medsystems, Inc. II May-23-2024
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