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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
Failure to cycle 5
Deployment issue 5
Break 5
Mechanics altered 3
Mechanical jam 3
Failure to deploy 3
Device ingredient or reagent issue 3
Difficult to open or close 2
Difficult to deploy 2
Failure to fold 1
Fail-safe mechanism issue 1
No Known Device Problem 1
Retraction problem 1
Failure to fire 1
Bent 1
Expulsion 1
Sticking 1
Malposition of device 1
Device markings issue 1
Positioning Issue 1
Premature deployment 1
Slippage of device or device component 1
Total Device Problems 258

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