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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)
2019 2020 2021 2022 2023 2024
4 2 1 0 1 0

MDR Year MDR Reports MDR Events
2019 80 80
2020 37 37
2021 40 40
2022 58 58
2023 59 59
2024 32 32

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 216 216
Break 20 20
Adverse Event Without Identified Device or Use Problem 11 11
Unintended Movement 7 7
Unintended Electrical Shock 6 6
Defective Component 4 4
Flare or Flash 4 4
Fracture 3 3
Imprecision 3 3
No Apparent Adverse Event 3 3
Shielding Failure 3 3
Detachment of Device or Device Component 2 2
Noise, Audible 2 2
Crack 2 2
Difficult or Delayed Positioning 1 1
Material Disintegration 1 1
Display Difficult to Read 1 1
No Display/Image 1 1
Signal Artifact/Noise 1 1
Material Fragmentation 1 1
Misfire 1 1
Device Tipped Over 1 1
Calibration Problem 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
Patient Device Interaction Problem 1 1
Output below Specifications 1 1
Output Problem 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
Vibration 1 1
Improper or Incorrect Procedure or Method 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Activation Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 175 175
No Consequences Or Impact To Patient 90 90
No Known Impact Or Consequence To Patient 12 12
Insufficient Information 5 5
Laceration(s) 3 3
Pain 3 3
Breast Cancer 2 2
Bone Fracture(s) 2 2
Death 2 2
Electric Shock 2 2
Neck Pain 2 2
Skin Tears 1 1
Discomfort 1 1
No Code Available 1 1
Asystole 1 1
Respiratory Arrest 1 1
Breast Discomfort/Pain 1 1
Skin Infection 1 1
Swelling/ Edema 1 1
Superficial (First Degree) Burn 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Dyspnea 1 1
Ecchymosis 1 1
Fatigue 1 1
Syncope 1 1
Abrasion 1 1
Bradycardia 1 1
Bruise/Contusion 1 1
Headache 1 1
Cardiac Arrest 1 1
Tissue Damage 1 1
Transient Ischemic Attack 1 1

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