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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device handle, scalpel
Product CodeGDZ
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 9 9
2020 4 4
2021 4 4
2022 5 5
2023 10 10
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Break 19 19
Retraction Problem 5 5
Device-Device Incompatibility 5 5
Mechanical Problem 4 4
Unsealed Device Packaging 4 4
Detachment of Device or Device Component 2 2
No Apparent Adverse Event 2 2
Device Fell 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Twisted/Bent 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21 21
No Patient Involvement 6 6
No Consequences Or Impact To Patient 5 5
Laceration(s) 4 4
Insufficient Information 3 3
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
2 Steris Corporation II Oct-12-2022
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