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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device digital breast tomosynthesis
Definition To generate digital 3D mammographic images that can be used for the screening and diagnosis of breast cancer.
Product CodeOTE
Device Class 3

Premarket Approvals (PMA)
2018 2019 2020 2021 2022 2023
2 4 2 1 0 1

MDR Year MDR Reports MDR Events
2018 87 87
2019 80 80
2020 37 37
2021 40 40
2022 58 58
2023 46 46

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 201 201
Poor Quality Image 21 21
Break 17 17
Device Displays Incorrect Message 16 16
Adverse Event Without Identified Device or Use Problem 10 10
Unintended Movement 9 9
Calibration Problem 7 7
Unintended Electrical Shock 6 6
Shielding Failure 5 5
No Display/Image 5 5
Crack 4 4
Defective Component 4 4
Flare or Flash 4 4
No Apparent Adverse Event 3 3
Device Stops Intermittently 3 3
Fracture 3 3
Collapse 3 3
Imprecision 3 3
Leak/Splash 3 3
Signal Artifact/Noise 2 2
Detachment of Device or Device Component 2 2
Device Operational Issue 2 2
Noise, Audible 2 2
Patient Device Interaction Problem 1 1
Intermittent Loss of Power 1 1
Appropriate Term/Code Not Available 1 1
Activation Failure 1 1
Unexpected Shutdown 1 1
Excessive Heating 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Fail-Safe Did Not Operate 1 1
Device Markings/Labelling Problem 1 1
Device Operates Differently Than Expected 1 1
Improper or Incorrect Procedure or Method 1 1
Output below Specifications 1 1
Output Problem 1 1
Positioning Problem 1 1
Misfire 1 1
Defective Device 1 1
Device Tipped Over 1 1
Computer Operating System Problem 1 1
Loss of Data 1 1
Overheating of Device 1 1
Loss of Power 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Fragmentation 1 1
Difficult or Delayed Positioning 1 1
Material Disintegration 1 1
Display Difficult to Read 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 135 135
No Consequences Or Impact To Patient 106 106
Not Applicable 56 56
No Known Impact Or Consequence To Patient 20 20
Insufficient Information 4 4
Electric Shock 3 3
No Code Available 3 3
Laceration(s) 3 3
Pain 3 3
Breast Cancer 2 2
Death 2 2
Bone Fracture(s) 2 2
Headache 1 1
Syncope 1 1
Bruise/Contusion 1 1
Ecchymosis 1 1
Fatigue 1 1
Tissue Damage 1 1
Transient Ischemic Attack 1 1
Misdiagnosis 1 1
Discomfort 1 1
Neck Pain 1 1
Skin Tears 1 1
Breast Discomfort/Pain 1 1
Skin Infection 1 1
Swelling/ Edema 1 1
No Patient Involvement 1 1
Superficial (First Degree) Burn 1 1
No Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hologic, Inc. II Feb-21-2023
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