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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device source, brachytherapy, radionuclide
Product CodeKXK
Regulation Number 892.5730
Device Class 2


Premarket Reviews
ManufacturerDecision
CIVATECH ONCOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 1
GT MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 3
ISORAY MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
LV LIBERTY VISION CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
RADIANCE THERAPEUTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 10 10
2020 15 15
2021 62 62
2022 26 26
2023 9 9
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Physical Resistance/Sticking 59 59
Inaccurate Information 11 11
Adverse Event Without Identified Device or Use Problem 10 10
Inadequate Instructions for Healthcare Professional 5 5
Device Contamination with Chemical or Other Material 5 5
Positioning Failure 5 5
Component Missing 4 4
Fitting Problem 3 3
Output Problem 3 3
Mechanical Jam 3 3
Lack of Maintenance Documentation or Guidelines 3 3
Insufficient Information 3 3
Missing Information 3 3
Material Twisted/Bent 3 3
Labelling, Instructions for Use or Training Problem 3 3
Failure to Discharge 2 2
Break 2 2
Device Markings/Labelling Problem 2 2
Wrong Label 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Integrity Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Unintended Ejection 2 2
Packaging Problem 2 2
Appropriate Term/Code Not Available 1 1
Failure to Advance 1 1
Component Misassembled 1 1
Installation-Related Problem 1 1
Detachment of Device or Device Component 1 1
Material Deformation 1 1
Difficult to Insert 1 1
Material Fragmentation 1 1
Microbial Contamination of Device 1 1
Contamination 1 1
Radiation Overexposure 1 1
Positioning Problem 1 1
Defective Device 1 1
Unsealed Device Packaging 1 1
Unclear Information 1 1
Patient-Device Incompatibility 1 1
Accessory Incompatible 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 100 100
No Known Impact Or Consequence To Patient 12 12
No Consequences Or Impact To Patient 10 10
No Patient Involvement 8 8
Post Operative Wound Infection 6 6
Necrosis 3 3
Unintended Radiation Exposure 3 3
Needle Stick/Puncture 2 2
Insufficient Information 2 2
Cerebral Edema 2 2
Unspecified Infection 1 1
Arthralgia 1 1
Death 1 1
Urinary Incontinence 1 1
Inflammation 1 1
Incontinence 1 1
Urinary Retention 1 1
Dyspnea 1 1
Pain 1 1
Myocardial Infarction 1 1
Ambulation Difficulties 1 1

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