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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 2

MDR Year MDR Reports MDR Events
2019 80 80
2020 37 37
2021 40 40
2022 58 58
2023 59 59
2024 85 85

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 253 253
Break 23 23
Adverse Event Without Identified Device or Use Problem 12 12
Unintended Movement 10 10
Unintended Electrical Shock 6 6
Fracture 5 5
Defective Component 4 4
Flare or Flash 4 4
Shielding Failure 3 3
Vibration 3 3
Computer Software Problem 3 3
Imprecision 3 3
No Apparent Adverse Event 3 3
Noise, Audible 2 2
Crack 2 2
Detachment of Device or Device Component 2 2
Output below Specifications 1 1
Loss of Data 1 1
Improper or Incorrect Procedure or Method 1 1
Loss of Power 1 1
Overheating of Device 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Excessive Heating 1 1
Appropriate Term/Code Not Available 1 1
Activation Failure 1 1
Computer Operating System Problem 1 1
Calibration Problem 1 1
Difficult or Delayed Positioning 1 1
Misfire 1 1
Material Fragmentation 1 1
Patient Device Interaction Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Fail-Safe Did Not Operate 1 1
Insufficient Information 1 1
Material Disintegration 1 1
Device Markings/Labelling Problem 1 1
Display Difficult to Read 1 1
Output Problem 1 1
Device Tipped Over 1 1
Mechanical Problem 1 1
No Display/Image 1 1
Unexpected Shutdown 1 1
Signal Artifact/Noise 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 224 224
No Consequences Or Impact To Patient 90 90
No Known Impact Or Consequence To Patient 12 12
Insufficient Information 5 5
Laceration(s) 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Pain 3 3
Death 2 2
Electric Shock 2 2
Breast Cancer 2 2
Bone Fracture(s) 2 2
Neck Pain 2 2
Cancer 2 2
Swollen Lymph Nodes/Glands 2 2
Abdominal Pain 1 1
Superficial (First Degree) Burn 1 1
Skin Infection 1 1
Syncope 1 1
Fatigue 1 1
No Code Available 1 1
Respiratory Arrest 1 1
Unspecified Gastrointestinal Problem 1 1
Abrasion 1 1
Cardiac Arrest 1 1
Transient Ischemic Attack 1 1
Discomfort 1 1
Dyspnea 1 1
Ecchymosis 1 1
Bradycardia 1 1
Asystole 1 1
Pulmonary Edema 1 1
Swelling/ Edema 1 1
Tissue Damage 1 1
Skin Tears 1 1
Headache 1 1
Ascites 1 1
Bruise/Contusion 1 1
Breast Discomfort/Pain 1 1

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