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

Premarket Reviews
Manufacturer	Decision
ATC TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
GYNESONICS, INC
	SUBSTANTIALLY EQUIVALENT	3
GYNESONICS, INC.
	SUBSTANTIALLY EQUIVALENT	3
INTEGRA LIFESCIENCES CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
LINA MEDICAL APS
	SUBSTANTIALLY EQUIVALENT	1
MEDSYS, S.A.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	34	34
Material Separation	19	19
Fire	12	12
Detachment of Device or Device Component	12	12
Sparking	7	7
Failure to Cut	6	6
Thermal Decomposition of Device	6	6
Material Fragmentation	6	6
Adverse Event Without Identified Device or Use Problem	5	5
Insufficient Information	5	5
Smoking	5	5
Melted	4	4
Overheating of Device	4	4
Improper or Incorrect Procedure or Method	4	4
Temperature Problem	4	4
Fracture	3	3
Electrical /Electronic Property Problem	3	3
Material Twisted/Bent	2	2
Torn Material	2	2
Crack	2	2
Detachment Of Device Component	2	2
Therapy Delivered to Incorrect Body Area	2	2
Device Contamination with Chemical or Other Material	2	2
Device Handling Problem	2	2
Material Integrity Problem	2	2
Defective Component	2	2
Fitting Problem	2	2
Material Frayed	2	2
Material Rupture	1	1
Misassembled	1	1
Material Deformation	1	1
Retraction Problem	1	1
Device Disinfection Or Sterilization Issue	1	1
Product Quality Problem	1	1
Mechanical Problem	1	1
Entrapment of Device	1	1
Dull, Blunt	1	1
Noise, Audible	1	1
Physical Resistance/Sticking	1	1
Separation Problem	1	1
Unintended Electrical Shock	1	1
Material Disintegration	1	1
Patient-Device Incompatibility	1	1
Unintended Movement	1	1
Difficult to Remove	1	1
Patient Device Interaction Problem	1	1
Contamination /Decontamination Problem	1	1
Arcing	1	1
Difficult to Open or Close	1	1
Metal Shedding Debris	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	45	45
No Clinical Signs, Symptoms or Conditions	36	36
No Consequences Or Impact To Patient	23	23
Burn(s)	10	10
Insufficient Information	7	7
Partial thickness (Second Degree) Burn	7	7
Hemorrhage/Bleeding	6	6
Foreign Body In Patient	5	5
Device Embedded In Tissue or Plaque	4	4
No Information	3	3
Injury	3	3
No Patient Involvement	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Electric Shock	2	2
Unspecified Reproductive System or Breast Problem	2	2
Abdominal Pain	1	1
Patient Problem/Medical Problem	1	1
No Code Available	1	1
Perforation	1	1
Burn, Thermal	1	1
Laceration(s)	1	1
Pain	1	1
Hormonal Imbalance	1	1
Internal Organ Perforation	1	1
Liver Laceration(s)	1	1