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TPLC
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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 Code
OTE
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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