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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, remote-controlled
Product CodeJAQ
Regulation Number 892.5700
Device Class 2


Premarket Reviews
ManufacturerDecision
BEST MEDICAL INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BRAXX BIOTECH CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
C4 IMAGING LLC
  SUBSTANTIALLY EQUIVALENT 1
GEOMED MEDIZIN-TECHNIK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
MICK RADIO-NUCLEAR INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NUCLETRON BV
  SUBSTANTIALLY EQUIVALENT 1
VARIAN MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
VARIAN MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 2
VARIAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 6

MDR Year MDR Reports MDR Events
2018 2 2
2019 8 8
2020 8 8
2021 5 5
2022 5 5
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 8 8
Use of Device Problem 3 3
Fracture 2 2
Material Separation 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Twisted/Bent 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Insufficient Information 1 1
Material Split, Cut or Torn 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Shipping Damage or Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Misassembled 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Retraction Problem 1 1
Computer Software Problem 1 1
Crack 1 1
Positioning Failure 1 1
Application Program Problem: Dose Calculation Error 1 1
Fluid/Blood Leak 1 1
Material Perforation 1 1
Obstruction of Flow 1 1
Expiration Date Error 1 1
Malposition of Device 1 1
Component or Accessory Incompatibility 1 1
Connection Problem 1 1
Detachment of Device or Device Component 1 1
Device Dislodged or Dislocated 1 1
Device Contaminated During Manufacture or Shipping 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 8 8
No Known Impact Or Consequence To Patient 6 6
No Clinical Signs, Symptoms or Conditions 6 6
No Information 4 4
Insufficient Information 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Device Embedded In Tissue or Plaque 1 1
Wound Dehiscence 1 1
Exposure to Body Fluids 1 1
Radiation Burn 1 1
Hemorrhage/Bleeding 1 1
Laceration(s) 1 1
Oversedation 1 1
Discomfort 1 1
Blood Loss 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Nucletron BV II Jan-02-2020
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