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TPLC
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show TPLC since
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Device
laparoscopic contraceptive tubal occlusion device
Definition
Call for PMAs to be filed by 12/30/87 (52 FR 36883 (10/1/87))
Product Code
KNH
Regulation Number
884.5380
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
4
9
12
5
0
2
1
9
2
0
1
2
2
1
1
0
MDR Year
MDR Reports
MDR Events
2014
82
82
2015
65
65
2016
63
63
2017
105
105
2018
112
112
2019
59
59
2020
47
47
2021
24
24
2022
20
20
2023
6
6
2024
6
6
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
113
113
Migration or Expulsion of Device
97
97
Patient-Device Incompatibility
75
75
Insufficient Information
56
56
Break
46
46
Migration
33
33
Device Operates Differently Than Expected
21
21
Unsealed Device Packaging
20
20
Device Dislodged or Dislocated
19
19
Appropriate Term/Code Not Available
18
18
Detachment Of Device Component
16
16
Difficult to Remove
15
15
Detachment of Device or Device Component
14
14
Entrapment of Device
13
13
Positioning Failure
11
11
Malposition of Device
9
9
Activation, Positioning or Separation Problem
7
7
Defective Device
7
7
Improper or Incorrect Procedure or Method
7
7
Difficult to Insert
6
6
Use of Device Problem
5
5
Misfire
5
5
Expulsion
4
4
Bent
4
4
Material Separation
4
4
Therapeutic or Diagnostic Output Failure
4
4
Patient Device Interaction Problem
3
3
No Apparent Adverse Event
3
3
Premature Activation
3
3
Mechanical Problem
3
3
Expiration Date Error
3
3
Device Or Device Fragments Location Unknown
3
3
Separation Failure
3
3
Failure to Fire
2
2
Delivered as Unsterile Product
2
2
Device Inoperable
2
2
Extrusion
2
2
Positioning Problem
2
2
Difficult to Open or Close
2
2
Mechanics Altered
2
2
Material Deformation
2
2
Material Fragmentation
2
2
Labelling, Instructions for Use or Training Problem
2
2
Loose or Intermittent Connection
2
2
Difficult or Delayed Positioning
2
2
Unintended Movement
2
2
Firing Problem
1
1
Sharp Edges
1
1
Device Fell
1
1
Difficult or Delayed Separation
1
1
Failure to Discharge
1
1
Component Falling
1
1
Degraded
1
1
Unintended Ejection
1
1
Fracture
1
1
Nonstandard Device
1
1
Off-Label Use
1
1
Product Quality Problem
1
1
Difficult To Position
1
1
Device Slipped
1
1
Sticking
1
1
Stretched
1
1
Fitting Problem
1
1
Material Perforation
1
1
Defective Component
1
1
Component Missing
1
1
Tear, Rip or Hole in Device Packaging
1
1
Structural Problem
1
1
Failure to Advance
1
1
Material Integrity Problem
1
1
Material Protrusion/Extrusion
1
1
Material Twisted/Bent
1
1
Mechanical Jam
1
1
Protective Measures Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Human-Device Interface Problem
1
1
Device Markings/Labelling Problem
1
1
Device Packaging Compromised
1
1
Difficult to Advance
1
1
Retraction Problem
1
1
Split
1
1
Difficult or Delayed Activation
1
1
Biocompatibility
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
308
309
Heavier Menses
103
103
Headache
91
91
Abdominal Pain
90
90
Menstrual Irregularities
72
72
Fatigue
66
66
Weight Changes
61
62
Emotional Changes
58
58
Anxiety
53
53
Depression
53
54
No Code Available
46
46
Hair Loss
42
43
Hemorrhage/Bleeding
41
41
No Known Impact Or Consequence To Patient
41
41
Foreign Body In Patient
35
35
Abdominal Distention
32
32
Cyst(s)
32
32
Cramp(s)
31
31
Dizziness
30
30
Nausea
29
29
Failure of Implant
26
26
Unspecified Infection
25
26
Memory Loss/Impairment
24
25
No Consequences Or Impact To Patient
24
24
Rash
21
21
Tissue Damage
19
19
Complaint, Ill-Defined
19
20
Sleep Dysfunction
19
19
Insufficient Information
18
18
Hot Flashes/Flushes
18
18
Hypersensitivity/Allergic reaction
18
18
Burning Sensation
17
17
Reaction
17
17
Sweating
17
17
Abdominal Cramps
17
17
Pregnancy
16
16
Inadequate Pain Relief
16
16
Disability
16
16
Swelling
16
16
Inflammation
16
16
Injury
15
15
Device Embedded In Tissue or Plaque
14
14
No Information
13
13
Irritability
13
13
Discomfort
12
12
Arthralgia
12
12
Laceration(s)
12
12
Itching Sensation
11
11
Anemia
11
12
Thrombus
11
11
Ambulation Difficulties
11
11
Confusion/ Disorientation
11
11
Intermenstrual Bleeding
10
10
Urinary Tract Infection
10
10
Autoimmune Disorder
10
10
Dyspnea
10
10
High Blood Pressure/ Hypertension
10
10
Vomiting
9
9
Scar Tissue
9
9
Patient Problem/Medical Problem
9
9
Cognitive Changes
9
9
Palpitations
9
9
No Patient Involvement
8
8
Constipation
8
8
Tingling
8
8
Perforation
8
8
Adhesion(s)
7
7
Internal Organ Perforation
7
7
Fibrosis
7
7
Blurred Vision
6
6
Rupture
6
6
Myalgia
6
6
Numbness
6
6
Ectopic Pregnancy
6
6
Autoimmune Reaction
5
5
Bacterial Infection
5
5
Vessel Or Plaque, Device Embedded In
5
5
Incontinence
5
5
Uterine Perforation
5
5
Thyroid Problems
5
6
Blood Loss
5
5
No Clinical Signs, Symptoms or Conditions
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Test Result
4
4
Hematuria
4
4
Fungal Infection
4
4
Tachycardia
4
5
Skin Discoloration
4
4
Scarring
4
4
Malaise
4
4
Urticaria
4
4
Flatus
4
4
Muscle Spasm(s)
4
4
Chest Pain
4
4
Fever
4
4
Fainting
3
3
Abscess
3
3
Arthritis
3
3
Miscarriage
3
3
Nerve Damage
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
Gyrus Acmi, Incorporated
II
Jun-26-2015
2
Gyrus Medical, Inc
II
Aug-19-2014
3
Gyrus Medical, Inc
II
Mar-13-2014
4
Richard Wolf Medical Instruments Corp.
II
Nov-06-2014
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