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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
Regulation Description Obstetric-gynecologic specialized manual instrument.
Product CodeHFB
Regulation Number 884.4530
Device Class 1

MDR Year MDR Reports MDR Events
2020 11 11
2021 8 8
2022 3 3
2023 1 1
2024 2 2
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 5 5
Difficult to Open or Close 5 5
Defective Device 4 4
Break 3 3
Physical Resistance/Sticking 2 2
Patient Device Interaction Problem 2 2
Failure to Align 2 2
Structural Problem 2 2
Failure to Cut 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Separation 2 2
Mechanical Jam 2 2
Dull, Blunt 2 2
Insufficient Information 1 1
Difficult to Remove 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemorrhage/Bleeding 9 9
No Clinical Signs, Symptoms or Conditions 8 8
No Known Impact Or Consequence To Patient 8 8
Discomfort 3 3
Insufficient Information 2 2
Pain 2 2
Laceration(s) 1 1
Skin Tears 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Sklar Instruments II Jan-16-2025
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