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	172	172
Mechanical Jam	58	58
Difficult to Open or Close	41	41
Use of Device Problem	36	36
Break	27	27
Dull, Blunt	24	24
Material Deformation	19	19
Material Integrity Problem	11	11
Device-Device Incompatibility	9	9
Mechanical Problem	9	9
Corroded	6	6
Component Missing	5	5
No Apparent Adverse Event	3	3
Appropriate Term/Code Not Available	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
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
Sharp Edges	1	1
Material Rupture	1	1
Product Quality Problem	1	1
Detachment of Device or Device Component	1	1
Firing Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	308	308
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
Hemorrhage/Bleeding	1	1

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