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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device retractor, self-retaining
Regulation Description Manual gastroenterology-urology surgical instrument and accessories.
Product CodeFFO
Regulation Number 876.4730
Device Class 1

MDR Year MDR Reports MDR Events
2020 2 2
2022 3 3
2023 2 2
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Separation Problem 1 1
Break 1 1
Unsealed Device Packaging 1 1
Defective Component 1 1
Failure to Clean Adequately 1 1
Component Missing 1 1
Material Deformation 1 1
Packaging Problem 1 1
Product Quality Problem 1 1
Excessive Heating 1 1
Loose or Intermittent Connection 1 1
Arcing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
Insufficient Information 2 2
No Known Impact Or Consequence To Patient 1 1
Burn(s) 1 1
No Consequences Or Impact To Patient 1 1

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