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	105	105
Material Deformation	66	66
Difficult to Advance	16	16
Device-Device Incompatibility	15	15
Detachment of Device or Device Component	15	15
Use of Device Problem	13	13
Unintended Movement	10	10
Failure to Cut	9	9
Misfire	9	9
Mechanical Problem	7	7
Failure to Fire	6	6
Packaging Problem	5	5
Mechanical Jam	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
Material Split, Cut or Torn	3	3
Difficult to Open or Close	3	3
Activation Problem	3	3
Therapeutic or Diagnostic Output Failure	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Material Twisted/Bent	3	3
Delivered as Unsterile Product	2	2
Shipping Damage or Problem	2	2
Defective Component	2	2
Entrapment of Device	2	2
Activation, Positioning or Separation Problem	2	2
Difficult or Delayed Activation	1	1
Difficult to Insert	1	1
Device Damaged by Another Device	1	1
Material Fragmentation	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
Protective Measures Problem	1	1
Appropriate Term/Code Not Available	1	1
Flushing Problem	1	1
Unintended System Motion	1	1
Connection Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	307	307
Insufficient Information	28	28
Foreign Body In Patient	10	10
Aortic Valve Insufficiency/ Regurgitation	5	5
Ischemic Heart Disease	3	3
Laceration(s)	3	3
Perforation	2	2
Valvular Insufficiency/ Regurgitation	2	2
Pericardial Effusion	2	2
Chest Pain	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
Foreign Body Embolism	1	1
Endocarditis	1	1
Hemorrhage/Bleeding	1	1
Tissue Breakdown	1	1