TPLC - Total Product Life Cycle

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

MDR Year	MDR Reports	MDR Events
2018	28	28
2019	36	36
2020	59	59
2021	63	63
2022	76	76

Device Problems	MDRs with this Device Problem	Events in those MDRs
Degraded	80	80
Break	44	44
Mechanical Jam	21	21
Dull, Blunt	20	20
Difficult to Open or Close	19	19
Use of Device Problem	13	13
Failure to Cut	13	13
Mechanical Problem	10	10
Material Integrity Problem	9	9
Corroded	6	6
Device-Device Incompatibility	5	5
Material Deformation	5	5
Material Twisted/Bent	5	5
Component Missing	5	5
No Apparent Adverse Event	4	4
Appropriate Term/Code Not Available	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Material Separation	3	3
Device Operates Differently Than Expected	3	3
Physical Resistance/Sticking	3	3
Failure to Fire	2	2
Positioning Problem	2	2
Material Split, Cut or Torn	2	2
Defective Device	2	2
Detachment of Device or Device Component	2	2
Premature Activation	2	2
Nonstandard Device	1	1
Structural Problem	1	1
Activation Problem	1	1
No Fail-Safe Mechanism	1	1
Packaging Problem	1	1
Firing Problem	1	1
Sharp Edges	1	1
Material Rupture	1	1
Device Damaged Prior to Use	1	1
Product Quality Problem	1	1
Failure to Read Input Signal	1	1
Device Inoperable	1	1
Improper or Incorrect Procedure or Method	1	1
Fitting Problem	1	1
Fracture	1	1
Inaccurate Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	148	148
No Consequences Or Impact To Patient	89	89
No Known Impact Or Consequence To Patient	13	13
Not Applicable	7	7
No Code Available	3	3
No Patient Involvement	3	3
No Information	2	2
Hemorrhage/Bleeding	1	1
Hematoma	1	1
Laceration(s)	1	1
Injury	1	1