TPLC - Total Product Life Cycle

• Device: unit, cryotherapy, ophthalmic
• Product Code: HQA
• Regulation Number: 886.4170
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2017	1	1
2018	2	2
2019	21	21
2020	9	9
2021	15	15
2022	5	5
2023	1	1
2024	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Temperature Problem	11	11
Leak/Splash	5	5
Excessive Cooling	5	5
Therapeutic or Diagnostic Output Failure	5	5
Pressure Problem	4	4
Material Fragmentation	4	4
Break	3	3
Defective Component	3	3
Operating System Becomes Nonfunctional	2	2
Mechanical Problem	2	2
Output Problem	2	2
Physical Resistance/Sticking	2	2
Defective Device	2	2
Structural Problem	2	2
Detachment of Device or Device Component	2	2
Suction Problem	2	2
Device Displays Incorrect Message	2	2
Failure to Read Input Signal	1	1
Material Split, Cut or Torn	1	1
No Display/Image	1	1
Device Damaged Prior to Use	1	1
Difficult to Remove	1	1
Unable to Obtain Readings	1	1
Material Twisted/Bent	1	1
Infusion or Flow Problem	1	1
Excess Flow or Over-Infusion	1	1
Inappropriate/Inadequate Shock/Stimulation	1	1
Insufficient Heating	1	1
Intermittent Continuity	1	1
Flaked	1	1
Material Puncture/Hole	1	1
Material Rupture	1	1
Calibration Problem	1	1
Appropriate Term/Code Not Available	1	1
Increase in Pressure	1	1
Insufficient Cooling	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	26	26
Insufficient Information	17	17
No Clinical Signs, Symptoms or Conditions	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Tingling	1	1
Electric Shock	1	1
No Information	1	1
Chemical Exposure	1	1
Numbness	1	1
No Consequences Or Impact To Patient	1	1