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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device apparatus, suturing, stomach and intestinal
Regulation Description Manual surgical instrument for general use.
Product CodeFHM
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2020 5 5
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Form Staple 3 3
Misfire 2 2
Mechanics Altered 2 2
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 4 4
No Clinical Signs, Symptoms or Conditions 2 2
Tissue Damage 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Consequences Or Impact To Patient 1 1

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