TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	34	34
Mechanical Jam	15	15
Corroded	12	12
Physical Resistance/Sticking	11	11
Mechanical Problem	8	8
Insufficient Information	7	7
Detachment of Device or Device Component	7	7
Failure to Cut	5	5
Entrapment of Device	4	4
Material Fragmentation	4	4
Improper or Incorrect Procedure or Method	4	4
Adverse Event Without Identified Device or Use Problem	3	3
Packaging Problem	3	3
Material Separation	3	3
Dull, Blunt	3	3
Device Markings/Labelling Problem	2	2
Material Integrity Problem	2	2
Difficult to Remove	2	2
Misfire	2	2
Separation Failure	1	1
No Pressure	1	1
Use of Device Problem	1	1
Component Missing	1	1
Difficult or Delayed Activation	1	1
Mechanics Altered	1	1
Delivered as Unsterile Product	1	1
Pitted	1	1
Difficult to Open or Close	1	1
Failure to Disconnect	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	99	99
Insufficient Information	23	23
Foreign Body In Patient	8	8
Vascular Dissection	4	4
Unspecified Tissue Injury	4	4
Perforation of Vessels	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
No Patient Involvement	2	2
Laceration(s)	2	2
Rupture	1	1
Cardiac Tamponade	1	1
Cardiac Perforation	1	1
No Consequences Or Impact To Patient	1	1
Unspecified Vascular Problem	1	1
Low Blood Pressure/ Hypotension	1	1