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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
2017 11 11
2018 7 7
2019 9 9
2020 4 4
2021 4 4
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 12 12
Mechanical Problem 11 11
Retraction Problem 11 11
Material Integrity Problem 4 4
Material Protrusion/Extrusion 4 4
Protective Measures Problem 2 2
Detachment of Device or Device Component 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Misassembled 2 2
Overheating of Device 2 2
Device Difficult to Setup or Prepare 1 1
Device-Device Incompatibility 1 1
Device Fell 1 1
Detachment Of Device Component 1 1
Entrapment of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 13 13
No Consequences Or Impact To Patient 12 12
No Clinical Signs, Symptoms or Conditions 4 4
Laceration(s) 2 2
Burn, Thermal 2 2
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Teleflex Medical II Oct-16-2017
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