TPLC - Total Product Life Cycle

show TPLC since

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

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
19	22	9	16	13	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	605	605
Material Puncture/Hole	173	173
Use of Device Problem	78	78
Detachment of Device or Device Component	44	44
Material Deformation	39	39
Appropriate Term/Code Not Available	29	29
Therapeutic or Diagnostic Output Failure	26	26
Device Displays Incorrect Message	25	25
Insufficient Information	24	24
Defective Device	23	23
Material Split, Cut or Torn	18	18
Mechanical Problem	12	12
Output Problem	11	11
Improper or Incorrect Procedure or Method	10	10
Protective Measures Problem	9	9
Fluid/Blood Leak	8	8
Melted	8	8
Device Alarm System	7	7
Material Twisted/Bent	7	7
Leak/Splash	6	6
Off-Label Use	6	6
Temperature Problem	5	5
Break	5	5
No Apparent Adverse Event	5	5
Energy Output Problem	5	6
Difficult to Open or Close	5	6
Activation Failure	4	5
Power Problem	4	4
Suction Failure	4	4
Activation, Positioning or Separation Problem	3	3
Material Separation	3	3
Activation Problem	3	3
Patient-Device Incompatibility	3	3
Material Integrity Problem	3	3
Electrical Shorting	2	2
Failure to Power Up	2	2
Unable to Obtain Readings	2	2
Material Fragmentation	2	2
Insufficient Cooling	2	2
Display or Visual Feedback Problem	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Defective Component	2	2
Collapse	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

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	386	387
Uterine Perforation	377	377
Bowel Burn	87	87
Foreign Body In Patient	62	62
Insufficient Information	56	58
Pain	55	55
Burn(s)	53	53
Abdominal Pain	41	41
Bowel Perforation	36	36
No Known Impact Or Consequence To Patient	30	30
No Consequences Or Impact To Patient	24	24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	19	19
Unspecified Infection	19	19
Hemorrhage/Bleeding	19	19
Bacterial Infection	17	17
Intermenstrual Bleeding	17	17
Bradycardia	15	15
Sepsis	14	14
Cardiac Arrest	14	14
Fever	11	11
Abscess	8	8
Partial thickness (Second Degree) Burn	8	8
Burn, Thermal	8	8
Superficial (First Degree) Burn	7	7
Cramp(s) /Muscle Spasm(s)	7	8
Nausea	6	6
Necrosis	6	6
Perforation	6	6
Hematoma	6	6
Vomiting	5	5
Abnormal Vaginal Discharge	5	5
Unspecified Tissue Injury	4	4
Discomfort	4	4
Pelvic Inflammatory Disease	4	4
Premature Menopause	4	4
No Code Available	4	4
Abdominal Cramps	3	3
Full thickness (Third Degree) Burn	3	3
Cervical Changes	3	3
Menstrual Irregularities	3	3
Blood Loss	2	2
Sexual Dysfunction	2	2
Fibrosis	2	2
Post Operative Wound Infection	2	2
Peritonitis	2	2
Urinary Incontinence	2	2
Electric Shock	2	2
Urinary Tract Infection	2	2
Menorrhagia	2	2
Tissue Damage	2	2