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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
2021 15 15
2022 3 4
2023 1 1
2024 2 2
2025 40 40
2026 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Unsealed Device Packaging 15 15
Tear, Rip or Hole in Device Packaging 15 15
Device Contamination with Chemical or Other Material 8 8
Leak/Splash 5 5
Air/Gas in Device 5 5
Material Twisted/Bent 4 4
Break 3 3
Physical Resistance/Sticking 3 3
Material Deformation 3 3
Complete Blockage 2 2
Contamination 2 2
Decoupling 2 2
Loss of or Failure to Bond 2 2
Malposition of Device 1 1
Emergency Power Failure 1 1
Difficult to Advance 1 1
Failure to Deliver 1 1
Material Fragmentation 1 1
Improper Flow or Infusion 1 1
Insufficient Flow or Under Infusion 1 1
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 53 53
Insufficient Information 11 12
Restless Legs Syndrome 1 1
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Sirtex Medical Limited II Mar-18-2021
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