TPLC - Total Product Life Cycle

show TPLC since

Device	instrument, ligature passing and knot tying
Product Code	HCF
Regulation Number	878.4800
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	91	91
Material Deformation	17	17
Difficult to Advance	14	14
Misfire	13	13
Use of Device Problem	12	12
Detachment of Device or Device Component	12	12
Device-Device Incompatibility	8	8
Insufficient Information	8	8
Material Twisted/Bent	7	7
Failure to Cut	6	6
Unintended Movement	6	6
Mechanical Jam	5	5
Adverse Event Without Identified Device or Use Problem	4	4
Difficult to Open or Close	4	4
Defective Device	4	4
Failure to Fire	4	4
Mechanical Problem	4	4
Crack	4	4
Physical Resistance/Sticking	4	4
Packaging Problem	3	3
Fracture	3	3
Entrapment of Device	2	2
Defective Component	2	2
Loose or Intermittent Connection	2	2
Activation, Positioning or Separation Problem	2	2
Output Problem	2	2
Appropriate Term/Code Not Available	2	2
Material Split, Cut or Torn	2	2
Firing Problem	1	1
No Apparent Adverse Event	1	1
Activation Problem	1	1
Device Contaminated During Manufacture or Shipping	1	1
Device Damaged by Another Device	1	1
Component Missing	1	1
Failure to Advance	1	1
Malposition of Device	1	1
Connection Problem	1	1
Flushing Problem	1	1
Difficult to Insert	1	1
Positioning Failure	1	1
Material Disintegration	1	1
Difficult to Remove	1	1
Improper or Incorrect Procedure or Method	1	1
Fitting Problem	1	1
Failure to Disconnect	1	1
Separation Failure	1	1
Difficult or Delayed Activation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	149	149
No Consequences Or Impact To Patient	36	36
Insufficient Information	20	20
No Known Impact Or Consequence To Patient	9	9
Foreign Body In Patient	7	7
Not Applicable	7	7
Aortic Valve Insufficiency/ Regurgitation	5	5
Mitral Valve Insufficiency/ Regurgitation	2	2
Unspecified Tissue Injury	2	2
Pericardial Effusion	2	2
Valvular Insufficiency/ Regurgitation	2	2
Laceration(s)	2	2
Cardiac Perforation	2	2
No Patient Involvement	2	2
Chest Pain	2	2
Death	1	1
Endocarditis	1	1
Unspecified Infection	1	1
Injury	1	1
Ischemic Heart Disease	1	1
Aortic Regurgitation	1	1
Atrial Fibrillation	1	1
Cusp Tear	1	1
Tissue Breakdown	1	1
Vascular Dissection	1	1
Syncope/Fainting	1	1
No Code Available	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1