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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 CodeKNH
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 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 112 112
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 306 307
Heavier Menses 103 103
Headache 90 90
Abdominal Pain 88 88
Menstrual Irregularities 72 72
Fatigue 66 66
Weight Changes 60 61
Emotional Changes 57 57
Anxiety 52 52
Depression 52 53
No Code Available 46 46
No Known Impact Or Consequence To Patient 41 41
Hair Loss 41 42
Hemorrhage/Bleeding 40 40
Foreign Body In Patient 35 35
Abdominal Distention 32 32
Cyst(s) 32 32
Cramp(s) 31 31
Dizziness 30 30
Nausea 29 29
Unspecified Infection 25 26
Failure of Implant 24 24
No Consequences Or Impact To Patient 24 24
Memory Loss/Impairment 23 24
Rash 21 21
Tissue Damage 19 19
Complaint, Ill-Defined 19 20
Hot Flashes/Flushes 18 18
Hypersensitivity/Allergic reaction 18 18
Sleep Dysfunction 18 18
Abdominal Cramps 17 17
Insufficient Information 17 17
Burning Sensation 17 17
Reaction 17 17
Sweating 17 17
Disability 16 16
Inadequate Pain Relief 16 16
Swelling 16 16
Inflammation 16 16
Pregnancy 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 10 10
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
Palpitations 9 9
Cognitive Changes 9 9
Patient Problem/Medical Problem 9 9
No Patient Involvement 8 8
Tingling 8 8
Perforation 8 8
Adhesion(s) 7 7
Internal Organ Perforation 7 7
Constipation 7 7
Fibrosis 7 7
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
Blurred Vision 5 5
Uterine Perforation 5 5
Thyroid Problems 5 6
No Clinical Signs, Symptoms or Conditions 5 5
Blood Loss 5 5
Hematuria 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Test Result 4 4
Tachycardia 4 5
Scarring 4 4
Fungal Infection 4 4
Urticaria 4 4
Malaise 4 4
Fever 4 4
Muscle Spasm(s) 4 4
Chest Pain 4 4
Flatus 4 4
Fainting 3 3
Arthritis 3 3
Abscess 3 3
Miscarriage 3 3
Nerve Damage 3 3
Toxicity 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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