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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 2
BRAXX BIOTECH CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
C4 IMAGING LLC
  SUBSTANTIALLY EQUIVALENT 1
CIANNA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CIANNA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ECKERT & ZIEGLER BEBIG GMBH
  SUBSTANTIALLY EQUIVALENT 1
GC MEDTECH, LLC
  SUBSTANTIALLY EQUIVALENT 2
GEOMED MEDIZIN-TECHNIK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
HOLOGIC, INC.
  SE - WITH LIMITATIONS 2
ICAD, INC.
  SUBSTANTIALLY EQUIVALENT 1
KOBOLD, LLC
  SUBSTANTIALLY EQUIVALENT 3
MICK RADIO-NUCLEAR INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 5
NUCLETRON
  SUBSTANTIALLY EQUIVALENT 2
NUCLETRON B.V.
  SUBSTANTIALLY EQUIVALENT 4
NUCLETRON BV
  SUBSTANTIALLY EQUIVALENT 3
NUCLETRON CORP.
  SUBSTANTIALLY EQUIVALENT 2
NUCLETRON CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PHOTON TECHNOLOGIES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
RADIADYNE
  SUBSTANTIALLY EQUIVALENT 1
RADIADYNE, LLC (SPECIFICATION DEVELOPER)
  SUBSTANTIALLY EQUIVALENT 1
SENORX, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPENCER FILLMORE
  SUBSTANTIALLY EQUIVALENT 3
VARIAN MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 2
VARIAN MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 8
VARIAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 25
VIVARAY, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 18 18
2015 7 7
2016 3 3
2017 5 5
2018 2 2
2019 8 8
2020 8 8
2021 5 5
2022 5 5
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 9 9
Adverse Event Without Identified Device or Use Problem 6 6
Use of Device Problem 5 5
Material Integrity Problem 5 5
Device Operates Differently Than Expected 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Difficult to Remove 4 4
Improper or Incorrect Procedure or Method 3 3
Computer Software Problem 3 3
Device Disinfection Or Sterilization Issue 3 3
Insufficient Information 3 3
Fluid/Blood Leak 2 2
Malposition of Device 2 2
Material Separation 2 2
Positioning Failure 2 2
Fracture 2 2
Material Twisted/Bent 2 2
Obstruction of Flow 2 2
Application Program Problem: Dose Calculation Error 2 2
Device Displays Incorrect Message 1 1
Connection Problem 1 1
Output below Specifications 1 1
Misassembled 1 1
Deflation Problem 1 1
Shipping Damage or Problem 1 1
Device Dislodged or Dislocated 1 1
Material Split, Cut or Torn 1 1
Retraction Problem 1 1
Component Missing 1 1
Expiration Date Error 1 1
Burst Container or Vessel 1 1
Physical Resistance 1 1
Product Quality Problem 1 1
Loss of Data 1 1
Component or Accessory Incompatibility 1 1
Device Contaminated During Manufacture or Shipping 1 1
Inadequacy of Device Shape and/or Size 1 1
Leak/Splash 1 1
Material Deformation 1 1
Material Rupture 1 1
Difficult to Insert 1 1
Detachment of Device or Device Component 1 1
Crack 1 1
Labelling, Instructions for Use or Training Problem 1 1
Defective Device 1 1
Material Perforation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 13 13
Foreign Body In Patient 9 9
No Information 9 9
No Clinical Signs, Symptoms or Conditions 7 7
No Code Available 4 4
Insufficient Information 4 4
No Patient Involvement 4 4
Radiation Underdose 4 4
Pain 3 3
Radiation Overdose 2 2
Hemorrhage/Bleeding 2 2
High Blood Pressure/ Hypertension 1 1
Unspecified Infection 1 1
Inflammation 1 1
Laceration(s) 1 1
Nausea 1 1
Necrosis 1 1
Oversedation 1 1
Dysphasia 1 1
No Consequences Or Impact To Patient 1 1
Discomfort 1 1
Injury 1 1
Numbness 1 1
Sleep Dysfunction 1 1
Underdose 1 1
Blood Loss 1 1
Abrasion 1 1
Exposure to Body Fluids 1 1
Radiation Burn 1 1
Erythema 1 1
Fatigue 1 1
Swelling 1 1
Weakness 1 1
Wound Dehiscence 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Nucletron BV II Jan-02-2020
2 Siemens Medical Solutions USA, Inc II Jun-01-2009
3 Varian Medical Systems Inc II Jun-26-2015
4 Varian Medical Systems Inc II Jun-23-2015
5 Varian Medical Systems, Inc. II Oct-24-2013
6 Varian Medical Systems, Inc. II May-15-2013
7 Varian Medical Systems, Inc. II Jan-31-2013
8 Varian Medical Systems, Inc. II Dec-20-2012
9 Varian Medical Systems, Inc. II Mar-12-2012
10 Varian Medical Systems, Inc. II Dec-01-2011
11 Varian Medical Systems, Inc. II Dec-01-2011
12 Varian Medical Systems, Inc. II Nov-30-2011
13 Varian Medical Systems, Inc. II Nov-23-2011
14 Varian Medical Systems, Inc. Oncology Systems II Dec-01-2011
15 Varian Medical Systems, Inc. Oncology Systems II Aug-22-2011
16 Varian Medical Systems, Inc. Oncology Systems II Aug-12-2011
17 Varian Medical Systems, Inc. Oncology Systems II Aug-11-2011
18 Varian Medical Systems, Inc. Oncology Systems II Aug-10-2011
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