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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device forceps, biopsy, gynecological
Product CodeHFB
Regulation Number 884.4530
Device Class 1

MDR Year MDR Reports MDR Events
2014 5 5
2015 1 1
2016 1 1
2018 8 8
2019 6 6
2020 11 11
2021 8 8
2022 3 3
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Open or Close 11 11
Mechanical Problem 6 6
Defective Device 4 4
Failure to Deliver Energy 4 4
Mechanical Jam 3 3
Break 3 3
Failure to Cut 3 3
Activation, Positioning or Separation Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Failure to Fire 2 2
Dull, Blunt 2 2
Material Separation 2 2
Physical Resistance/Sticking 2 2
Material Deformation 1 1
Detachment Of Device Component 1 1
Sticking 1 1
Failure to Obtain Sample 1 1
Mechanics Altered 1 1
Flaked 1 1
Insufficient Information 1 1
Difficult to Remove 1 1
Retraction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 16 16
No Clinical Signs, Symptoms or Conditions 8 8
Pain 7 7
Hemorrhage/Bleeding 4 4
No Consequences Or Impact To Patient 3 3
Discomfort 2 2
Injury 2 2
Insufficient Information 2 2
Blood Loss 2 2
Laceration(s) 1 1
Skin Tears 1 1

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