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 Code	OTE
Device Class	3

Premarket Approvals (PMA)
2019	2020	2021	2022	2023	2024
4	2	1	0	1	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended System Motion	264	264
Break	23	23
Adverse Event Without Identified Device or Use Problem	12	12
Unintended Movement	11	11
Unintended Electrical Shock	6	6
Fracture	5	5
Vibration	5	5
Defective Component	4	4
Flare or Flash	4	4
No Apparent Adverse Event	3	3
Shielding Failure	3	3
Imprecision	3	3
Computer Software Problem	3	3
Crack	2	2
Noise, Audible	2	2
Detachment of Device or Device Component	2	2
Device Markings/Labelling Problem	1	1
Material Twisted/Bent	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
Patient Device Interaction Problem	1	1
Output below Specifications	1	1
Output Problem	1	1
Insufficient Information	1	1
Appropriate Term/Code Not Available	1	1
Activation Failure	1	1
Difficult or Delayed Positioning	1	1
Material Disintegration	1	1
Display Difficult to Read	1	1
No Display/Image	1	1
Mechanical Problem	1	1
Material Fragmentation	1	1
Signal Artifact/Noise	1	1
Improper or Incorrect Procedure or Method	1	1
Overheating of Device	1	1
Loss of Power	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Unexpected Shutdown	1	1
Excessive Heating	1	1
Application Program Freezes, Becomes Nonfunctional	1	1
Fail-Safe Did Not Operate	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	237	237
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
Unspecified Tissue Injury	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