TPLC - Total Product Life Cycle

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Device	coagulator-cutter, endoscopic, unipolar (and accessories)
Product Code	KNF
Regulation Number	884.4160
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	20	20
Material Separation	18	18
Detachment of Device or Device Component	11	11
Insufficient Information	4	4
Sparking	4	4
Melted	4	4
Fire	3	3
Fracture	3	3
Material Fragmentation	3	3
Smoking	3	3
Improper or Incorrect Procedure or Method	3	3
Failure to Cut	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Temperature Problem	2	2
Material Integrity Problem	2	2
Material Twisted/Bent	2	2
Fitting Problem	2	2
Overheating of Device	2	2
Product Quality Problem	1	1
Therapy Delivered to Incorrect Body Area	1	1
Difficult to Remove	1	1
Material Rupture	1	1
Material Frayed	1	1
Mechanical Problem	1	1
Defective Component	1	1
Dull, Blunt	1	1
Patient-Device Incompatibility	1	1
Crack	1	1
Difficult to Open or Close	1	1
Device Contamination with Chemical or Other Material	1	1
Material Deformation	1	1
Patient Device Interaction Problem	1	1
Physical Resistance/Sticking	1	1
Separation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	36	36
No Consequences Or Impact To Patient	19	19
No Known Impact Or Consequence To Patient	7	7
Insufficient Information	7	7
Partial thickness (Second Degree) Burn	6	6
Foreign Body In Patient	5	5
Burn(s)	5	5
Hemorrhage/Bleeding	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Unspecified Reproductive System or Breast Problem	2	2
Patient Problem/Medical Problem	1	1
Device Embedded In Tissue or Plaque	1	1
Hormonal Imbalance	1	1
Laceration(s)	1	1
Liver Laceration(s)	1	1
Injury	1	1
Electric Shock	1	1
No Patient Involvement	1	1