TPLC - Total Product Life Cycle

• Device: cutter, surgical
• Product Code: FZT
• Regulation Number: 878.4800
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2019	36	36
2020	59	59
2021	63	63
2022	76	76
2023	60	60
2024	15	15

Device Problems	MDRs with this Device Problem	Events in those MDRs
Degraded	120	120
Break	39	39
Mechanical Jam	33	33
Difficult to Open or Close	26	26
Use of Device Problem	25	25
Dull, Blunt	21	21
Material Deformation	14	14
Failure to Cut	12	12
Material Integrity Problem	10	10
Mechanical Problem	9	9
Device-Device Incompatibility	8	8
Corroded	6	6
Material Twisted/Bent	5	5
Component Missing	5	5
No Apparent Adverse Event	4	4
Material Split, Cut or Torn	2	2
Appropriate Term/Code Not Available	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Failure to Fire	2	2
Defective Device	2	2
Premature Activation	2	2
Packaging Problem	1	1
No Fail-Safe Mechanism	1	1
Detachment of Device or Device Component	1	1
Positioning Problem	1	1
Firing Problem	1	1
Material Rupture	1	1
Device Damaged Prior to Use	1	1
Sharp Edges	1	1
Fitting Problem	1	1
Physical Resistance/Sticking	1	1
Material Separation	1	1
Inaccurate Information	1	1
Product Quality Problem	1	1
Activation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	220	220
No Consequences Or Impact To Patient	75	75
Not Applicable	7	7
No Patient Involvement	3	3
Foreign Body In Patient	2	2
No Known Impact Or Consequence To Patient	1	1
Injury	1	1
Hematoma	1	1
Hemorrhage/Bleeding	1	1
Laceration(s)	1	1