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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 42
Failure to Adhere or Bond 33
Misfire 21
Mechanical issue 18
Delivery system failure 15
No Information 8
Failure to form staple 8
Failure to align 6
Material twisted 6
Deployment issue 5
Break 5
Failure to cycle 5
Failure to deploy 3
Device ingredient or reagent issue 3
Mechanical jam 3
Mechanics altered 3
Difficult to open or close 2
Difficult to deploy 2
Product quality issue 2
Retraction problem 1
Slippage of device or device component 1
Sticking 1
Failure to fire 1
Malposition of device 1
Bent 1
Failure to fold 1
Premature deployment 1
Expulsion 1
Fail-safe mechanism issue 1
Device markings issue 1
No Known Device Problem 1
Positioning Issue 1
Total Device Problems 260

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