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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device apparatus, suturing, stomach and intestinal
Product CodeFHM
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 3 3
2020 5 5
2024 1 1

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 4 4
No Consequences Or Impact To Patient 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Tissue Damage 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Information 1 1

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