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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, applicator, radionuclide, manual
Regulation Description Manual radionuclide applicator system.
Product CodeIWJ
Regulation Number 892.5650
Device Class 1

MDR Year MDR Reports MDR Events
2020 5 5
2021 15 15
2022 3 3
2023 1 1
2024 2 2
2025 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 8 8
Unsealed Device Packaging 5 5
Tear, Rip or Hole in Device Packaging 5 5
Physical Resistance/Sticking 4 4
Therapeutic or Diagnostic Output Failure 3 3
Material Twisted/Bent 3 3
Connection Problem 2 2
Leak/Splash 1 1
Fitting Problem 1 1
Activation, Positioning or Separation Problem 1 1
Break 1 1
Malposition of Device 1 1
Output Problem 1 1
Difficult to Advance 1 1
Positioning Problem 1 1
Material Fragmentation 1 1
Positioning Failure 1 1
Detachment of Device or Device Component 1 1
Device Dislodged or Dislocated 1 1
Device Displays Incorrect Message 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 27 27
No Known Impact Or Consequence To Patient 4 4
Insufficient Information 2 2
No Consequences Or Impact To Patient 2 2
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Riverpoint Medical, LLC II Jan-10-2020
2 Sirtex Medical Limited II Mar-18-2021
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