TPLC - Total Product Life Cycle

• Device: camera, surgical and accessories
• Product Code: KQM
• Regulation Number: 878.4160
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2017	5	5
2018	8	8
2019	6	6
2020	19	19
2021	9	9
2022	6	6

Device Problems	MDRs with this Device Problem	Events in those MDRs
Display or Visual Feedback Problem	7	7
Poor Quality Image	7	7
Insufficient Information	5	5
Device Fell	5	5
Detachment of Device or Device Component	4	4
No Display/Image	4	4
Break	4	4
Collapse	2	2
Misconnection	2	2
Corroded	2	2
Smoking	2	2
Structural Problem	2	2
Unexpected Shutdown	2	2
Power Problem	2	2
Appropriate Term/Code Not Available	1	1
Noise, Audible	1	1
Connection Problem	1	1
Unstable	1	1
Electrical Power Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Crack	1	1
Delivered as Unsterile Product	1	1
Unsealed Device Packaging	1	1
Loss of Power	1	1
Failure to Power Up	1	1
Inappropriate/Inadequate Shock/Stimulation	1	1
Detachment Of Device Component	1	1
Component Falling	1	1
Circuit Failure	1	1
Fracture	1	1
Image Display Error/Artifact	1	1
Mechanical Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	19	19
No Consequences Or Impact To Patient	14	14
No Known Impact Or Consequence To Patient	10	10
No Information	2	2
No Patient Involvement	2	2
Patient Problem/Medical Problem	1	1
Anxiety	1	1
Bruise/Contusion	1	1
Bone Fracture(s)	1	1
Head Injury	1	1
Pain	1	1
Insufficient Information	1	1
Not Applicable	1	1