TPLC - Total Product Life Cycle

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Device	instrument, ligature passing and knot tying
Regulation Description	Manual surgical instrument for general use.
Product Code	HCF
Regulation Number	878.4800
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	120	120
Material Deformation	73	73
Detachment of Device or Device Component	16	16
Difficult to Advance	16	16
Device-Device Incompatibility	15	15
Use of Device Problem	14	14
Misfire	11	11
Unintended Movement	10	10
Failure to Cut	9	9
Mechanical Problem	7	7
Failure to Fire	6	6
Mechanical Jam	5	5
Entrapment of Device	5	5
Packaging Problem	5	5
Material Split, Cut or Torn	4	4
Difficult to Open or Close	4	4
Output Problem	4	4
Physical Resistance/Sticking	4	4
Crack	4	4
Device Damaged Prior to Use	4	4
Insufficient Information	4	4
Defective Device	4	4
Improper or Incorrect Procedure or Method	3	3
Separation Problem	3	3
Activation Problem	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Therapeutic or Diagnostic Output Failure	3	3
Material Twisted/Bent	3	3
Shipping Damage or Problem	3	3
Delivered as Unsterile Product	2	2
Defective Component	2	2
Activation, Positioning or Separation Problem	2	2
Device Difficult to Setup or Prepare	1	1
Difficult to Insert	1	1
Component Missing	1	1
Difficult or Delayed Activation	1	1
Material Fragmentation	1	1
Difficult to Remove	1	1
Device Damaged by Another Device	1	1
Material Integrity Problem	1	1
Difficult or Delayed Positioning	1	1
Device Fell	1	1
Separation Failure	1	1
Retraction Problem	1	1
Material Disintegration	1	1
Device Markings/Labelling Problem	1	1
No Apparent Adverse Event	1	1
Activation Failure	1	1
Migration	1	1
Perivalvular Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	337	337
Insufficient Information	33	33
Foreign Body In Patient	10	10
Aortic Valve Insufficiency/ Regurgitation	5	5
Ischemic Heart Disease	3	3
Pericardial Effusion	3	3
Laceration(s)	3	3
Perforation	2	2
Valvular Insufficiency/ Regurgitation	2	2
Chest Pain	2	2
Foreign Body Embolism	2	2
Mitral Valve Insufficiency/ Regurgitation	2	2
Unspecified Tissue Injury	2	2
Syncope/Fainting	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Failure of Implant	1	1
Vascular Dissection	1	1
Atrial Fibrillation	1	1
Rupture	1	1
Cusp Tear	1	1
Cardiac Perforation	1	1
Endocarditis	1	1
Hemorrhage/Bleeding	1	1
Tissue Breakdown	1	1