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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device clip, implantable, reprocessed
Regulation Description Implantable clip.
Definition The "implantable clip, reprocessed" is intended to connect internal tissues to aid in healing. It is not absorbable. This device is indicated for reuse/reprocessing.
Product CodeNMJ
Regulation Number 878.4300
Device Class 2

Device Problems
Material deformation 19
Failure to Adhere or Bond 18
Device operates differently than expected 15
Delivery system failure 15
Mechanical issue 11
Misfire 10
Failure to align 5
Deployment issue 3
Mechanical jam 3
No Information 3
Material twisted 2
Failure to deploy 2
Break 2
Failure to form staple 2
Failure to fire 1
Malposition of device 1
Difficult to open or close 1
Expulsion 1
Fail-safe mechanism issue 1
Failure to cycle 1
Bent 1
Retraction problem 1
Slippage of device or device component 1
Device markings issue 1
Mechanics altered 1
Positioning Issue 1
Total Device Problems 122

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