TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	40	40
Material Fragmentation	16	16
Fracture	8	8
Mechanical Problem	2	2
Failure to Cut	2	2
Product Quality Problem	2	2
Activation, Positioning or Separation Problem	1	1
Material Disintegration	1	1
Insufficient Information	1	1
Material Integrity Problem	1	1
Material Discolored	1	1
Dent in Material	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Packaging Problem	1	1
Material Separation	1	1
Tear, Rip or Hole in Device Packaging	1	1
Detachment of Device or Device Component	1	1
Difficult to Open or Close	1	1
Flaked	1	1
Arcing	1	1
Dull, Blunt	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	72	72
Insufficient Information	9	9
Foreign Body In Patient	3	3
Laceration(s)	2	2
Post Operative Wound Infection	1	1
Burn(s)	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	MEDLINE INDUSTRIES, LP - Northfield	II	Dec-23-2024
2	MEDLINE INDUSTRIES, LP - Northfield	II	Nov-14-2024
3	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024
4	MEDLINE INDUSTRIES, LP - Northfield	II	Mar-29-2024
5	Medline Industries, LP	II	Dec-12-2025
6	Sklar Instruments	II	Jan-16-2025
7	Steris Corporation	II	Jan-17-2024
8	Stradis Medical, LLC dba Stradis Healthcare	II	Aug-18-2022