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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, endoscopic suturing
Regulation Description Endoscope and accessories.
Product CodeMFJ
Regulation Number 876.1500
Device Class 2

Device Problems
Detachment of device component 20
Break 9
Needle, separation 5
Device, or device fragments remain in patient 4
Other (for use when an appropriate device code cannot be identified) 4
Device Issue 3
Component(s), broken 3
Device remains implanted 2
Source, detachment from 2
Tip breakage 2
Torn material 2
No code available 1
Bicarbonate 1
Use of Device Issue 1
Unknown (for use when the device problem is not known) 1
Device damaged prior to use 1
Device or device fragments location unknown 1
Detachment of device or device component 1
Mechanical jam 1
Difficult to remove 1
Material separation 1
Failure to discharge 1
Difficult to insert 1
Total Device Problems 68

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