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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, occlusion, tubal, contraceptive, laparoscopic
Regulation Description Contraceptive tubal occlusion device (TOD) and introducer.
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)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
1 1 4 9 12 5 0 2 1 5

Device Problems
Patient-device incompatibility 283
No Information 171
Migration of device or device component 148
Break 140
No Known Device Problem 134
Difficult to remove 105
Dislodged or dislocated 74
Device operates differently than expected 70
No code available 60
Difficult to insert 54
Malposition of device 31
Material fragmentation 25
Extrusion 24
Unsealed device packaging 17
Unexpected therapeutic results 16
Difficult to deploy 16
Device or device fragments location unknown 16
Failure to separate 16
Bent 15
Entrapment of device or device component 15
Expulsion 14
Detachment of device or device component 13
Failure to deploy 12
Detachment of device component 10
Sticking 10
Improper or incorrect procedure or method 10
Product quality issue 9
Fracture 9
Stretched 8
Positioning Issue 8
Device handling issue 8
Therapeutic or diagnostic output failure 7
Material perforation 7
Unraveled material 6
Material separation 6
Occlusion within device 4
Defective item 4
Failure to advance 4
Material Protrusion 4
Material twisted 4
Unintended movement 3
Split 3
Use of Device Issue 3
Metal shedding debris 3
Mechanical issue 3
Difficult to position 3
Component falling 3
Degraded 2
Slippage of device or device component 2
Premature deployment 2
Uncoiled 2
Defective component 2
Failure to disconnect 2
Cut in material 2
Material deformation 2
Difficult to advance 2
Device or device component damaged by another device 1
Device packaging compromised 1
Human-Device Interface Issue 1
Inadequate instructions for non-healthcare professional 1
Manufacturing or shipping issue associated with device 1
Material integrity issue 1
Electromagnetic compatibility issue 1
Temperature issue 1
Noise, Audible 1
Structural problem 1
Misfire 1
Physical resistance 1
Arcing 1
Failure to fire 1
Folded 1
Chemical spillage 1
Deployment issue 1
Bacterial contamination of device 1
Component missing 1
Out-of-box failure 1
Implant, removal of 1
Implant, repositioning of 1
Loss of osseointegration 1
Obstruction within device 1
Device inoperable 1
Failure to unfold or unwrap 1
Unknown (for use when the device problem is not known) 1
Material puncture 1
Inadequate training 1
Failure to power-up 1
Kinked 1
Device maintenance issue 1
Delivered as unsterile product 1
Material frayed 1
Material erosion 1
False negative result 1
Unintended ejection 1
Contamination during use 1
Failure to Adhere or Bond 1
Total Device Problems 1665

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 3 1 0
Class III 0 0 0 0 0 0 0 0 0 0

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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