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TPLC
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show TPLC since
2009
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2014
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2016
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2019
2020
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2024
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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
MDR Year
MDR Reports
MDR Events
2014
309
309
2015
318
318
2016
295
295
2017
292
292
2018
262
262
2019
248
248
2020
197
197
2021
229
229
2022
179
179
2023
211
211
2024
146
146
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
Therapeutic or Diagnostic Output Failure
38
38
Device Alarm System
38
38
Break
32
32
Balloon leak(s)
30
30
Defective Device
28
28
Device Handling Problem
26
26
Detachment of Device or Device Component
22
22
Device Inoperable
22
22
Improper or Incorrect Procedure or Method
20
20
Leak/Splash
19
19
Positioning Problem
19
19
Device Contamination with Chemical or Other Material
18
18
Material Split, Cut or Torn
18
18
Mechanical Problem
16
16
Hole In Material
13
13
Loss of Power
13
13
Retraction Problem
11
11
Other (for use when an appropriate device code cannot be identified)
10
10
Material Perforation
10
10
Patient-Device Incompatibility
10
10
Material Integrity Problem
10
10
Difficult to Open or Close
10
10
Protective Measures Problem
9
9
Melted
9
9
Failure to Power Up
9
9
Output Problem
9
9
Electrical /Electronic Property Problem
8
8
Defective Component
8
8
Balloon burst
8
8
Material Twisted/Bent
7
7
Overheating of Device
7
7
Burst Container or Vessel
7
7
Noise, Audible
7
7
Temperature Problem
7
7
Failure to Advance
7
7
Smoking
7
7
No Apparent Adverse Event
7
7
Detachment Of Device Component
6
6
Display or Visual Feedback Problem
5
5
Positioning Failure
5
5
Suction 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
Injury
25
25
Abscess
25
25
Nausea
24
24
Intermenstrual Bleeding
21
21
Complaint, Ill-Defined
20
20
Bradycardia
20
20
Internal Organ Perforation
20
20
Abdominal Cramps
18
18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
17
17
Vomiting
17
17
Cardiac Arrest
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
Partial thickness (Second Degree) Burn
11
11
Vaso-Vagal Response
11
11
Blood Loss
11
11
Disability
11
11
Low Blood Pressure/ Hypotension
10
10
Test Result
10
10
Abnormal Vaginal Discharge
10
10
Hematoma
9
9
Necrosis
9
9
Headache
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
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