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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 9 9

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
Positioning Failure 5 5
Device Contamination with Chemical or Other Material 5 5
Component Missing 4 4
Output Problem 3 3
Mechanical Jam 3 3
Fitting Problem 3 3
Insufficient Information 3 3
Material Twisted/Bent 3 3
Labelling, Instructions for Use or Training Problem 3 3
Missing Information 3 3
Lack of Maintenance Documentation or Guidelines 3 3
Break 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Integrity Problem 2 2
Packaging Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Failure to Discharge 2 2
Unsealed Device Packaging 1 1
Defective Device 1 1
Radiation Overexposure 1 1
Positioning Problem 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Accessory Incompatible 1 1
Patient-Device Incompatibility 1 1
Unclear Information 1 1
Contamination 1 1
Microbial Contamination of Device 1 1
Material Fragmentation 1 1
Difficult to Insert 1 1
Material Deformation 1 1
Detachment of Device or Device Component 1 1
Component Misassembled 1 1
Installation-Related Problem 1 1
Appropriate Term/Code Not Available 1 1
Failure to Advance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 98 98
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
Needle Stick/Puncture 2 2
Insufficient Information 2 2
Cerebral Edema 2 2
Unspecified Infection 1 1
Death 1 1
Arthralgia 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
Unintended Radiation Exposure 1 1

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