TPLC - Total Product Life Cycle

• Device: scissors, general, surgical
• Product Code: LRW
• Regulation Number: 878.4800
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2019	39	39
2020	21	21
2021	17	17
2022	16	16
2023	7	7
2024	16	16

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	49	49
Material Fragmentation	19	19
Fracture	14	14
Material Integrity Problem	5	5
Mechanical Problem	5	5
Detachment of Device or Device Component	5	5
Device Markings/Labelling Problem	3	3
Product Quality Problem	3	3
Inaccurate Information	3	3
Mechanical Jam	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Device Fell	2	2
Material Separation	2	2
Component Missing	2	2
Structural Problem	2	2
Failure to Align	2	2
Failure to Cut	2	2
Defective Device	2	2
Difficult to Open or Close	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Dull, Blunt	1	1
Device Slipped	1	1
Pitted	1	1
Material Discolored	1	1
Flaked	1	1
Separation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	52	52
No Known Impact Or Consequence To Patient	22	22
No Consequences Or Impact To Patient	13	13
Insufficient Information	9	9
Foreign Body In Patient	7	7
No Patient Involvement	7	7
Device Embedded In Tissue or Plaque	3	3
Bowel Perforation	2	2
Failure of Implant	1	1
Injury	1	1
Fall	1	1
Laceration(s)	1	1
Pain	1	1
Tissue Damage	1	1
Ambulation Difficulties	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024
2	MEDLINE INDUSTRIES, LP - Northfield	II	Mar-29-2024
3	Steris Corporation	II	Jan-17-2024
4	Stradis Medical, LLC dba Stradis Healthcare	II	Aug-18-2022