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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device surgical instruments, g-u, manual (and accessories)
Product CodeKOA
Regulation Number 876.4730
Device Class 1

MDR Year MDR Reports MDR Events
2019 2 2
2020 1 1
2021 1 1
2023 5 5
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Break 2 2
Fracture 1 1
Material Separation 1 1
Improper or Incorrect Procedure or Method 1 1
Malposition of Device 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
No Code Available 2 2
Perforation 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Foreign Body In Patient 1 1
Insufficient Information 1 1
Failure to Anastomose 1 1
Perforation of Vessels 1 1
Tissue Damage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Jul-29-2022
2 Uromedica Inc. II Apr-28-2020
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