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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 57
Device operates differently than expected 34
Failure to Adhere or Bond 31
Misfire 21
Mechanical issue 18
Delivery system failure 15
Failure to form staple 8
No Information 8
Failure to align 6
Material twisted 6
Deployment issue 5
Break 5
Failure to cycle 5
Device ingredient or reagent issue 3
Mechanical jam 3
Mechanics altered 3
Failure to deploy 3
Difficult to open or close 2
Difficult to deploy 2
Bent 1
Premature deployment 1
Retraction problem 1
Slippage of device or device component 1
Sticking 1
Device markings issue 1
Failure to fire 1
Malposition of device 1
Expulsion 1
Fail-safe mechanism issue 1
No Known Device Problem 1
Positioning Issue 1
Failure to fold 1
Total Device Problems 248

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