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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)
2019 2020 2021 2022 2023 2024
8 19 22 9 16 2

MDR Year MDR Reports MDR Events
2019 248 248
2020 197 197
2021 229 229
2022 179 179
2023 211 211
2024 69 69

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 635 635
Material Puncture/Hole 92 92
Use of Device Problem 46 46
Appropriate Term/Code Not Available 42 42
Material Deformation 37 37
Device Displays Incorrect Message 36 36
Therapeutic or Diagnostic Output Failure 30 30
Fluid/Blood Leak 21 21
Insufficient Information 21 21
Defective Device 19 19
Detachment of Device or Device Component 18 18
Device Alarm System 16 16
Mechanical Problem 13 13
Material Split, Cut or Torn 10 10
Break 8 8
Protective Measures Problem 8 8
Output Problem 8 8
Material Integrity Problem 7 7
Material Twisted/Bent 6 6
Retraction Problem 6 6
Temperature Problem 5 5
No Apparent Adverse Event 5 5
Melted 5 5
Energy Output Problem 5 5
Improper or Incorrect Procedure or Method 5 5
Activation Failure 5 5
Suction Failure 4 4
Activation Problem 4 4
Unable to Obtain Readings 4 4
Off-Label Use 4 4
Crack 4 4
Leak/Splash 4 4
Material Separation 4 4
Defective Component 4 4
Difficult to Open or Close 4 4
Patient-Device Incompatibility 3 3
Power Problem 3 3
Display or Visual Feedback Problem 3 3
Failure to Power Up 3 3
Suction Problem 3 3
Unexpected Shutdown 3 3
No Display/Image 2 2
Material Fragmentation 2 2
Backflow 2 2
Activation, Positioning or Separation Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Failure to Fire 2 2
Failure to Calibrate 2 2
Failure to Align 1 1
Failure to Advance 1 1
Misfire 1 1
Self-Activation or Keying 1 1
Malposition of Device 1 1
Device Dislodged or Dislocated 1 1
Deformation Due to Compressive Stress 1 1
Calibration Problem 1 1
Communication or Transmission Problem 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
Material Protrusion/Extrusion 1 1
Positioning Problem 1 1
Thermal Decomposition of Device 1 1
Insufficient Cooling 1 1
Failure to Cycle 1 1
Decrease in Suction 1 1
Deflation Problem 1 1
Positioning Failure 1 1
Material Frayed 1 1
Difficult to Insert 1 1
Inadequate Instructions for Healthcare Professional 1 1
Filling Problem 1 1
Unintended Ejection 1 1
Fitting Problem 1 1
Device Damaged Prior to Use 1 1
Difficult to Remove 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Poor Quality Image 1 1
No Device Output 1 1
Unsealed Device Packaging 1 1
Loss of Power 1 1
Intermittent Energy Output 1 1
Excessive Heating 1 1
Device Handling Problem 1 1
Failure to Seal 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Uterine Perforation 350 350
No Clinical Signs, Symptoms or Conditions 209 209
Bowel Burn 81 81
No Known Impact Or Consequence To Patient 67 67
No Consequences Or Impact To Patient 61 61
Pain 56 56
Burn(s) 50 50
Insufficient Information 50 50
Bowel Perforation 33 33
Abdominal Pain 33 33
Unspecified Infection 33 33
Burn, Thermal 30 30
Foreign Body In Patient 29 29
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 17 17
Intermenstrual Bleeding 16 16
Hemorrhage/Bleeding 15 15
Bradycardia 14 14
Bacterial Infection 12 12
Sepsis 12 12
Cardiac Arrest 11 11
Fever 9 9
Abscess 9 9
Perforation 8 8
Partial thickness (Second Degree) Burn 8 8
No Code Available 8 8
Superficial (First Degree) Burn 7 7
Cramp(s) /Muscle Spasm(s) 6 6
Necrosis 5 5
Hematoma 4 4
Abnormal Vaginal Discharge 4 4
Urinary Frequency 4 4
Discomfort 4 4
Blood Loss 4 4
Premature Menopause 4 4
Unspecified Tissue Injury 3 3
Tissue Damage 3 3
Abdominal Cramps 3 3
Injury 3 3
Vomiting 3 3
Scar Tissue 3 3
Cervical Changes 3 3
Menstrual Irregularities 3 3
Pelvic Inflammatory Disease 3 3
Nausea 2 2
Neuropathy 2 2
Laceration(s) 2 2
Infiltration into Tissue 2 2
Pulmonary Embolism 2 2
Abrasion 2 2
Air Embolism 2 2
Peritonitis 2 2
Cramp(s) 2 2
Electric Shock 2 2
Heavier Menses 2 2
Weight Changes 2 2
No Patient Involvement 2 2
Urinary Incontinence 2 2
Nodule 2 2
Fibrosis 2 2
Full thickness (Third Degree) Burn 2 2
Device Embedded In Tissue or Plaque 1 1
Fluid Discharge 1 1
Tissue Breakdown 1 1
No Information 1 1
Pregnancy 1 1
Cancer 1 1
Sexual Dysfunction 1 1
Vesicovaginal Fistula 1 1
Unspecified Reproductive System or Breast Problem 1 1
Sexually Transmitted Infection 1 1
Blister 1 1
Intraoperative Pain 1 1
Dizziness 1 1
Swelling 1 1
Tachycardia 1 1
Ambulation Difficulties 1 1
Scarring 1 1
Rash 1 1
Burning Sensation 1 1
Impaired Healing 1 1
Numbness 1 1
Loss of consciousness 1 1
Skin Inflammation 1 1
Post Operative Wound Infection 1 1
Sleep Dysfunction 1 1
Anemia 1 1
Arrhythmia 1 1
Arthritis 1 1
Adhesion(s) 1 1
Cyst(s) 1 1
Death 1 1
Inflammation 1 1
Irritation 1 1
Ischemia 1 1
Low Blood Pressure/ Hypotension 1 1
Muscle Spasm(s) 1 1
Undesired Nerve Stimulation 1 1

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