TPLC - Total Product Life Cycle

show TPLC since

Device	device, thermal ablation, endometrial
Product Code	MNB
Device Class	3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
22	9	16	13	4	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	541	541
Material Puncture/Hole	186	186
Use of Device Problem	80	80
Detachment of Device or Device Component	49	49
Material Deformation	40	40
Insufficient Information	22	22
Material Split, Cut or Torn	18	18
Therapeutic or Diagnostic Output Failure	16	16
Defective Device	14	14
Mechanical Problem	11	11
Output Problem	11	11
Improper or Incorrect Procedure or Method	10	10
Protective Measures Problem	8	8
Material Twisted/Bent	7	7
Off-Label Use	6	6
No Apparent Adverse Event	6	6
Activation Failure	6	7
Melted	6	6
Leak/Splash	5	5
Fluid/Blood Leak	5	5
Energy Output Problem	5	6
Break	4	4
Difficult to Open or Close	4	5
Device Displays Incorrect Message	4	4
Activation, Positioning or Separation Problem	3	3
Failure to Seal	3	3
Material Separation	3	3
Activation Problem	3	3
Temperature Problem	3	3
Electrical Shorting	2	2
Failure to Advance	2	2
Unable to Obtain Readings	2	2
Material Fragmentation	2	2
Display or Visual Feedback Problem	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Patient-Device Incompatibility	2	2
Material Disintegration	2	2
Collapse	2	2
Suction Failure	2	2
Crack	2	2
Communication or Transmission Problem	2	2
Malposition of Device	2	2
Device Contamination with Body Fluid	2	2
No Display/Image	2	2
Unexpected Shutdown	2	2
Self-Activation or Keying	1	1
Insufficient Cooling	1	1
Electrical /Electronic Property Problem	1	1
Human-Device Interface Problem	1	1
False Positive Result	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	412	413
Uterine Perforation	330	330
Bowel Burn	75	75
Foreign Body In Patient	67	67
Burn(s)	53	53
Insufficient Information	52	54
Abdominal Pain	41	41
Pain	41	41
Bowel Perforation	34	34
Fever	21	21
Hemorrhage/Bleeding	21	21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	19	19
Unspecified Infection	18	18
Sepsis	17	17
Bacterial Infection	17	17
Bradycardia	15	15
Intermenstrual Bleeding	14	14
Cardiac Arrest	13	13
Pelvic Inflammatory Disease	10	10
Abscess	8	8
Superficial (First Degree) Burn	7	7
Partial thickness (Second Degree) Burn	7	7
Cramp(s) /Muscle Spasm(s)	7	8
Abnormal Vaginal Discharge	7	7
Chills	5	5
Vomiting	5	5
Hematoma	5	5
Necrosis	5	5
Nausea	5	5
Premature Menopause	4	4
Perforation	4	4
Menstrual Irregularities	4	4
Discomfort	3	3
Full thickness (Third Degree) Burn	3	3
Loss of consciousness	3	3
Anemia	3	3
Cervical Changes	3	3
Unspecified Tissue Injury	3	3
Septic Shock	2	2
Laceration(s)	2	2
Nodule	2	2
Fibrosis	2	2
Sexual Dysfunction	2	2
Peritonitis	2	2
Blister	2	2
Abdominal Cramps	2	2
Urinary Tract Infection	2	2
Electric Shock	2	2
Menorrhagia	2	2
Weight Changes	2	2