TPLC - Total Product Life Cycle

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

MDR Year	MDR Reports	MDR Events
2020	21	21
2021	17	17
2022	16	16
2023	7	7
2024	18	18
2025	4	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	33	33
Material Fragmentation	16	16
Fracture	10	10
Product Quality Problem	3	3
Mechanical Problem	2	2
Device Fell	2	2
Defective Device	2	2
Material Integrity Problem	2	2
Detachment of Device or Device Component	2	2
Device Slipped	1	1
Insufficient Information	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Discolored	1	1
Failure to Cut	1	1
Packaging Problem	1	1
Difficult to Open or Close	1	1
Flaked	1	1
Dull, Blunt	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	55	55
Insufficient Information	10	10
No Consequences Or Impact To Patient	7	7
No Known Impact Or Consequence To Patient	6	6
Foreign Body In Patient	4	4
Post Operative Wound Infection	1	1
No Patient Involvement	1	1
Laceration(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	Sklar Instruments	II	Jan-16-2025
6	Steris Corporation	II	Jan-17-2024
7	Stradis Medical, LLC dba Stradis Healthcare	II	Aug-18-2022