Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 9 9

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
Defective Device 7 7
Improper or Incorrect Procedure or Method 7 7
Activation, Positioning or Separation Problem 7 7
Difficult to Insert 6 6
Use of Device Problem 5 5
Misfire 5 5
Therapeutic or Diagnostic Output Failure 4 4
Material Separation 4 4
Bent 4 4
Expulsion 4 4
No Apparent Adverse Event 3 3
Expiration Date Error 3 3
Patient Device Interaction Problem 3 3
Device Or Device Fragments Location Unknown 3 3
Mechanical Problem 3 3
Separation Failure 3 3
Premature Activation 3 3
Failure to Fire 2 2
Labelling, Instructions for Use or Training Problem 2 2
Difficult or Delayed Positioning 2 2
Material Deformation 2 2
Delivered as Unsterile Product 2 2
Mechanics Altered 2 2
Material Fragmentation 2 2
Unintended Movement 2 2
Extrusion 2 2
Loose or Intermittent Connection 2 2
Device Inoperable 2 2
Positioning Problem 2 2
Difficult to Open or Close 2 2
Failure to Discharge 1 1
Component Falling 1 1
Biocompatibility 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 309 310
Heavier Menses 103 103
Headache 92 92
Abdominal Pain 91 91
Menstrual Irregularities 73 73
Fatigue 67 67
Weight Changes 62 63
Emotional Changes 58 58
Depression 53 54
Anxiety 53 53
No Code Available 46 46
Hair Loss 43 44
Hemorrhage/Bleeding 42 42
No Known Impact Or Consequence To Patient 41 41
Foreign Body In Patient 36 36
Abdominal Distention 32 32
Cyst(s) 32 32
Cramp(s) 31 31
Dizziness 30 30
Nausea 30 30
Failure of Implant 27 27
Unspecified Infection 25 26
No Consequences Or Impact To Patient 24 24
Memory Loss/Impairment 24 25
Rash 21 21
Complaint, Ill-Defined 19 20
Tissue Damage 19 19
Sleep Dysfunction 19 19
Hypersensitivity/Allergic reaction 18 18
Hot Flashes/Flushes 18 18
Insufficient Information 18 18
Sweating 17 17
Burning Sensation 17 17
Abdominal Cramps 17 17
Reaction 17 17
Pregnancy 16 16
Swelling 16 16
Inadequate Pain Relief 16 16
Inflammation 16 16
Disability 16 16
Injury 15 15
Device Embedded In Tissue or Plaque 14 14
Irritability 13 13
No Information 13 13
Arthralgia 12 12
Discomfort 12 12
Laceration(s) 12 12
High Blood Pressure/ Hypertension 11 11
Confusion/ Disorientation 11 11
Dyspnea 11 11

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
-
-