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	6	6

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	42	42
Material Fragmentation	19	19
Fracture	13	13
Material Integrity Problem	5	5
Mechanical Problem	5	5
Detachment of Device or Device Component	4	4
Device Markings/Labelling Problem	3	3
Inaccurate Information	3	3
Product Quality Problem	3	3
Device Fell	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Structural Problem	2	2
Component Missing	2	2
Failure to Cut	2	2
Mechanical Jam	2	2
Material Separation	2	2
Failure to Align	2	2
Defective Device	2	2
Separation Problem	1	1
Device Slipped	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Flaked	1	1
Dull, Blunt	1	1
Difficult to Open or Close	1	1
Material Discolored	1	1
Pitted	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	44	44
No Known Impact Or Consequence To Patient	22	22
No Consequences Or Impact To Patient	13	13
No Patient Involvement	7	7
Foreign Body In Patient	7	7
Insufficient Information	7	7
Device Embedded In Tissue or Plaque	3	3
Bowel Perforation	2	2
Injury	1	1
Ambulation Difficulties	1	1
Fall	1	1
Failure of Implant	1	1
Laceration(s)	1	1
Pain	1	1
Tissue Damage	1	1

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