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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
2018 7 7
2019 9 9
2020 4 4
2021 4 4
2022 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 15 15
Mechanical Problem 5 5
Retraction Problem 5 5
Material Integrity Problem 4 4
Material Protrusion/Extrusion 4 4
Detachment of Device or Device Component 2 2
Overheating of Device 2 2
Device-Device Incompatibility 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 10 10
No Clinical Signs, Symptoms or Conditions 8 8
No Consequences Or Impact To Patient 5 5
Burn, Thermal 2 2
Laceration(s) 2 2
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Steris Corporation II Oct-12-2022
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