TPLC - Total Product Life Cycle

show TPLC since

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

Premarket Approvals (PMA)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
13	18	18	8	17	20	7	5	8	9	8	19	22	9	16	9

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1116	1116
Insufficient Information	344	344
Device Operates Differently Than Expected	159	159
Fluid/Blood Leak	135	135
Material Puncture/Hole	107	107
Device Displays Incorrect Message	81	81
Appropriate Term/Code Not Available	59	59
Use of Device Problem	57	57
Material Deformation	40	40
Device Alarm System	38	38
Therapeutic or Diagnostic Output Failure	38	38
Break	32	32
Balloon leak(s)	30	30
Defective Device	28	28
Device Handling Problem	26	26
Device Inoperable	22	22
Detachment of Device or Device Component	22	22
Improper or Incorrect Procedure or Method	20	20
Leak/Splash	19	19
Positioning Problem	19	19
Material Split, Cut or Torn	18	18
Device Contamination with Chemical or Other Material	18	18
Mechanical Problem	16	16
Loss of Power	13	13
Hole In Material	13	13
Retraction Problem	11	11
Difficult to Open or Close	10	10
Patient-Device Incompatibility	10	10
Material Integrity Problem	10	10
Material Perforation	10	10
Other (for use when an appropriate device code cannot be identified)	10	10
Failure to Power Up	9	9
Protective Measures Problem	9	9
Output Problem	9	9
Melted	9	9
Electrical /Electronic Property Problem	8	8
Balloon burst	8	8
Defective Component	8	8
Material Twisted/Bent	7	7
No Apparent Adverse Event	7	7
Smoking	7	7
Temperature Problem	7	7
Burst Container or Vessel	7	7
Noise, Audible	7	7
Failure to Advance	7	7
Overheating of Device	7	7
Detachment Of Device Component	6	6
Display or Visual Feedback Problem	5	5
Activation, Positioning or Separation Problem	5	5
Fitting Problem	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Uterine Perforation	613	613
No Clinical Signs, Symptoms or Conditions	252	252
Pain	232	232
No Consequences Or Impact To Patient	230	230
Perforation	212	212
Burn(s)	206	206
No Known Impact Or Consequence To Patient	189	189
Abdominal Pain	128	128
Bowel Burn	125	125
Unspecified Infection	119	119
Hemorrhage/Bleeding	73	74
Burn, Thermal	73	73
No Code Available	68	68
Bowel Perforation	67	67
Fever	54	54
Insufficient Information	52	52
Sepsis	49	49
No Information	45	46
Foreign Body In Patient	36	36
Bacterial Infection	30	30
Cramp(s)	27	27
Tissue Damage	26	26
Abscess	25	25
Injury	25	25
Nausea	24	24
Intermenstrual Bleeding	21	21
Bradycardia	20	20
Complaint, Ill-Defined	20	20
Internal Organ Perforation	20	20
Abdominal Cramps	18	18
Cardiac Arrest	17	17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	17	17
Vomiting	17	17
Menstrual Irregularities	16	16
Heavier Menses	16	16
No Patient Involvement	15	15
Inflammation	15	15
Discomfort	14	14
Swelling	12	12
Adhesion(s)	12	12
Vaso-Vagal Response	11	11
Blood Loss	11	11
Partial thickness (Second Degree) Burn	11	11
Disability	11	11
Low Blood Pressure/ Hypotension	10	10
Abnormal Vaginal Discharge	10	10
Test Result	10	10
Necrosis	9	9
Superficial (First Degree) Burn	9	9
Hematoma	9	9

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Sep-22-2009
2	Channel Medsystems, Inc.	II	May-23-2024
3	Hologic, Inc	II	Feb-26-2014