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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device transcervical contraceptive tubal occlusion device
Regulation Description Contraceptive tubal occlusion device (TOD) and introducer.
Definition Call for PMAs 12/30/87 (52 FR 36883 10/1/87))
Product CodeHHS
Regulation Number 884.5380
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
2 4 7 2 2 7 1 1 2 5 0

Device Problems
Patient-device incompatibility 276
No Information 169
Migration of device or device component 145
Break 129
No Known Device Problem 107
Difficult to remove 101
Dislodged or dislocated 72
Device operates differently than expected 70
Difficult to insert 52
No code available 50
Malposition of device 33
Material fragmentation 25
Extrusion 24
Difficult to deploy 17
Unexpected therapeutic results 16
Bent 15
Device or device fragments location unknown 15
Failure to separate 14
Entrapment of device or device component 14
Failure to deploy 13
Detachment of device or device component 12
Expulsion 12
Improper or incorrect procedure or method 10
Sticking 10
Fracture 9
Detachment of device component 9
Product quality issue 8
Stretched 8
Positioning 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
Metal shedding debris 3
Difficult to position 3
Slippage of device or device component 3
Component falling 3
Degraded 2
Premature deployment 2
Loose or intermittent connection 2
Mechanical issue 2
Failure to disconnect 2
Misfire 2
Deployment issue 2
Capturing issue 2
Uncoiled 2
Device inoperable 2
Use of Device Issue 2
Defective component 2
Material deformation 2
Difficult to advance 2
Inadequate instructions for non-healthcare professional 1
Manufacturing or shipping issue associated with device 1
Device or device component damaged by another device 1
Electromagnetic compatibility issue 1
Material integrity issue 1
Temperature issue 1
Noise, Audible 1
Bacterial contamination of device 1
Component missing 1
Out-of-box failure 1
Loss of osseointegration 1
Obstruction within device 1
Cut in material 1
Structural problem 1
Low impedance 1
Undersensing 1
Failure to unfold or unwrap 1
Chemical spillage 1
Failure to fire 1
Folded 1
Physical resistance 1
Arcing 1
Oversensing 1
Material puncture 1
Failure to power-up 1
Tip breakage 1
Inadequate training 1
Failure to Adhere or Bond 1
Premature discharge of battery 1
Contamination during use 1
Material erosion 1
False negative result 1
Material frayed 1
Kinked 1
Total Device Problems 1569

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