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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 3

MDR Year MDR Reports MDR Events
2019 248 248
2020 197 197
2021 229 229
2022 179 179
2023 211 211
2024 111 111

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 646 646
Material Puncture/Hole 97 97
Use of Device Problem 48 48
Appropriate Term/Code Not Available 43 43
Material Deformation 37 37
Device Displays Incorrect Message 36 36
Therapeutic or Diagnostic Output Failure 30 30
Insufficient Information 21 21
Detachment of Device or Device Component 21 21
Fluid/Blood Leak 21 21
Defective Device 19 19
Material Split, Cut or Torn 17 17
Device Alarm System 16 16
Mechanical Problem 13 13
Break 8 8
Output Problem 8 8
Protective Measures Problem 8 8
Material Integrity Problem 7 7
Material Twisted/Bent 6 6
Improper or Incorrect Procedure or Method 6 6
Melted 6 6
Retraction Problem 6 6
Energy Output Problem 5 5
Temperature Problem 5 5
No Apparent Adverse Event 5 5
Activation Failure 5 5
Suction Failure 4 4
Activation Problem 4 4
Leak/Splash 4 4
Unable to Obtain Readings 4 4
Crack 4 4
Off-Label Use 4 4
Material Separation 4 4
Defective Component 4 4
Difficult to Open or Close 4 4
Suction Problem 3 3
Patient-Device Incompatibility 3 3
Display or Visual Feedback Problem 3 3
Failure to Power Up 3 3
Unexpected Shutdown 3 3
Power Problem 3 3
Mechanical Jam 2 2
No Display/Image 2 2
Backflow 2 2
Material Fragmentation 2 2
Failure to Calibrate 2 2
Activation, Positioning or Separation Problem 2 2
Failure to Fire 2 2
Electrical Shorting 2 2
Device Contamination with Chemical or Other Material 2 2
Inappropriate or Unexpected Reset 1 1
Installation-Related Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Malposition of Device 1 1
Device Dislodged or Dislocated 1 1
Material Protrusion/Extrusion 1 1
Measurement System Incompatibility 1 1
Positioning Problem 1 1
Failure to Align 1 1
Failure to Advance 1 1
Misfire 1 1
Deformation Due to Compressive Stress 1 1
Calibration Problem 1 1
Communication or Transmission Problem 1 1
Fitting Problem 1 1
Device Damaged Prior to Use 1 1
Device Contamination with Body Fluid 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
Failure to Cycle 1 1
Decrease in Suction 1 1
Deflation Problem 1 1
Positioning Failure 1 1
Thermal Decomposition of Device 1 1
Collapse 1 1
Insufficient Cooling 1 1
Poor Quality Image 1 1
No Device Output 1 1
Unsealed Device Packaging 1 1
Loss of Power 1 1
Decrease in Pressure 1 1
Self-Activation or Keying 1 1
Difficult to Remove 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Problem with Software Installation 1 1
Intermittent Energy Output 1 1
Excessive Heating 1 1
Failure to Seal 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Uterine Perforation 358 358
No Clinical Signs, Symptoms or Conditions 234 234
Bowel Burn 85 85
No Known Impact Or Consequence To Patient 67 67
No Consequences Or Impact To Patient 61 61
Pain 57 57
Burn(s) 51 51
Insufficient Information 51 51
Bowel Perforation 33 33
Abdominal Pain 33 33
Unspecified Infection 33 33
Foreign Body In Patient 32 32
Burn, Thermal 30 30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 17 17
Intermenstrual Bleeding 16 16
Hemorrhage/Bleeding 15 15
Bradycardia 14 14
Sepsis 13 13
Bacterial Infection 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

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