TPLC - Total Product Life Cycle

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Device	cutter, surgical
Regulation Description	Manual surgical instrument for general use.
Product Code	FZT
Regulation Number	878.4800
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Degraded	191	191
Mechanical Jam	67	67
Difficult to Open or Close	46	46
Use of Device Problem	38	38
Break	26	26
Dull, Blunt	25	25
Material Deformation	20	20
Device-Device Incompatibility	11	11
Material Integrity Problem	11	11
Mechanical Problem	9	9
Corroded	6	6
Component Missing	5	5
Appropriate Term/Code Not Available	5	5
No Apparent Adverse Event	3	3
Defective Device	2	2
Material Twisted/Bent	2	2
Failure to Cut	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Failure to Fire	2	2
Detachment of Device or Device Component	2	2
Premature Activation	2	2
Fitting Problem	1	1
Device Contaminated During Manufacture or Shipping	1	1
Material Split, Cut or Torn	1	1
Device Damaged Prior to Use	1	1
Difficult to Advance	1	1
No Fail-Safe Mechanism	1	1
Difficult to Remove	1	1
Sharp Edges	1	1
Material Rupture	1	1
Product Quality Problem	1	1
Firing Problem	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	338	338
No Consequences Or Impact To Patient	47	47
Not Applicable	3	3
Foreign Body In Patient	2	2
Hematoma	1	1
No Known Impact Or Consequence To Patient	1	1
Laceration(s)	1	1
Perforation of Vessels	1	1
Hemorrhage/Bleeding	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Sklar Instruments	II	Jan-16-2025