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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
Product CodeIWJ
Regulation Number 892.5650
Device Class 1

MDR Year MDR Reports MDR Events
2014 4 4
2015 2 2
2016 2 2
2017 7 7
2018 3 3
2019 5 5
2020 5 5
2021 15 15
2022 3 3
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Physical Resistance/Sticking 6 6
Break 6 6
Tear, Rip or Hole in Device Packaging 5 5
Unsealed Device Packaging 5 5
Positioning Problem 4 4
Material Twisted/Bent 3 3
Device Inoperable 3 3
Therapeutic or Diagnostic Output Failure 3 3
Bent 2 2
Solder Joint Fracture 2 2
Connection Problem 2 2
Mechanical Jam 2 2
Misfire 1 1
Difficult to Insert 1 1
Material Fragmentation 1 1
Entrapment of Device 1 1
Malposition of Device 1 1
Output Problem 1 1
Component Missing 1 1
Positioning Failure 1 1
Radiation Leak 1 1
Inadequate Instructions for Healthcare Professional 1 1
Contamination /Decontamination Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Failure to Discharge 1 1
Device Displays Incorrect Message 1 1
Improper or Incorrect Procedure or Method 1 1
Melted 1 1
Device Dislodged or Dislocated 1 1
Failure to Advance 1 1
Device Operates Differently Than Expected 1 1
Detachment of Device or Device Component 1 1
Sticking 1 1
Material Protrusion/Extrusion 1 1
Difficult to Advance 1 1
Device Damaged Prior to Use 1 1
Torn Material 1 1
Fitting Problem 1 1
Leak/Splash 1 1
Activation, Positioning or Separation Problem 1 1
Device Slipped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19 19
No Known Impact Or Consequence To Patient 19 19
No Consequences Or Impact To Patient 5 5
No Patient Involvement 4 4
Insufficient Information 2 2
Cancer 2 2
Radiation Exposure, Unintended 1 1
Missed Dose 1 1
No Information 1 1
Tissue Damage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medical Device Technologies, Inc. II Jul-13-2010
2 Riverpoint Medical, LLC II Jan-10-2020
3 Riverpoint Medical, LLC III Jan-28-2019
4 Sirtex Medical Limited II Mar-18-2021
5 Theragenics Corporation II Dec-19-2018
6 Worldwide Medical Technologies, LLC II Oct-12-2011
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