TPLC - Total Product Life Cycle

• Device: system, x-ray, mammographic
• Product Code: IZH
• Regulation Number: 892.1710
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
FUJIFILM CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
HOLOGIC, INC
	SUBSTANTIALLY EQUIVALENT	1
IMS GIOTTO S.P.A.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	39	39
2020	7	7
2021	9	9
2022	4	4
2023	8	8
2024	3	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended System Motion	27	27
Imprecision	11	11
Adverse Event Without Identified Device or Use Problem	5	5
Device Operational Issue	2	2
Device Fell	2	2
Positioning Failure	2	2
Poor Quality Image	2	2
Use of Device Problem	2	2
Defective Device	2	2
Malposition of Device	2	2
Application Program Problem	1	1
Calibration Problem	1	1
Communication or Transmission Problem	1	1
Detachment of Device or Device Component	1	1
Improper or Incorrect Procedure or Method	1	1
Device Contamination with Body Fluid	1	1
Failure to Obtain Sample	1	1
Break	1	1
Increase in Pressure	1	1
Material Separation	1	1
Erratic or Intermittent Display	1	1
Loose or Intermittent Connection	1	1
Moisture Damage	1	1
Unexpected Shutdown	1	1
Electrical Shorting	1	1
Flare or Flash	1	1
Mechanics Altered	1	1
Optical Problem	1	1
Output Problem	1	1
Unintended Movement	1	1
Activation Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	37	37
No Clinical Signs, Symptoms or Conditions	12	12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Skin Tears	3	3
Pain	3	3
Perforation	2	2
Hematoma	2	2
No Known Impact Or Consequence To Patient	2	2
Insufficient Information	2	2
Radiation Exposure, Unintended	1	1
Muscle/Tendon Damage	1	1
Unspecified Tissue Injury	1	1
Physical Entrapment	1	1
Deformity/ Disfigurement	1	1
Skin Inflammation	1	1
Hemorrhage/Bleeding	1	1
Unspecified Infection	1	1
Bruise/Contusion	1	1
Fainting	1	1
Scar Tissue	1	1
Tissue Damage	1	1