TPLC - Total Product Life Cycle

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Device	instruments, surgical, cardiovascular
Product Code	DWS
Regulation Number	870.4500
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	43	43
Corroded	20	20
Mechanical Jam	12	12
Adverse Event Without Identified Device or Use Problem	10	10
Physical Resistance/Sticking	10	10
Detachment of Device or Device Component	8	8
Mechanical Problem	7	7
Material Fragmentation	6	6
Insufficient Information	4	4
Fracture	3	3
Failure to Cut	3	3
Difficult to Open or Close	3	3
Entrapment of Device	3	3
Material Separation	3	3
Component Missing	3	3
Misfire	2	2
Improper or Incorrect Procedure or Method	2	2
Difficult to Remove	2	2
Leak/Splash	2	2
Packaging Problem	2	2
Noise, Audible	1	1
Device Fell	1	1
Material Integrity Problem	1	1
Mechanics Altered	1	1
Device Markings/Labelling Problem	1	1
Loose or Intermittent Connection	1	1
Pitted	1	1
Material Erosion	1	1
Crack	1	1
Material Too Rigid or Stiff	1	1
Material Perforation	1	1
Failure to Disconnect	1	1
Separation Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	78	78
No Consequences Or Impact To Patient	18	18
No Patient Involvement	18	18
No Information	10	10
Insufficient Information	9	9
No Known Impact Or Consequence To Patient	8	8
Tissue Damage	8	8
Foreign Body In Patient	7	7
Unspecified Tissue Injury	4	4
Vascular Dissection	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Perforation of Vessels	2	3
Cardiac Perforation	2	2
Laceration(s)	2	2
Blood Loss	1	1
Cardiac Tamponade	1	1
Death	1	1
Low Blood Pressure/ Hypotension	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Cook Vandergrift, Inc.	II	Sep-01-2023
2	Deroyal Industries, Inc. Lafollette	II	Feb-19-2020
3	Maquet Cardiovascular, LLC	II	Jul-31-2023
4	Maquet Cardiovascular, LLC	II	Apr-12-2022
5	TELEFLEX MEDICAL INC	II	Jan-27-2020