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	2
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
Detachment of Device or Device Component	12	12
Fire	12	12
Sparking	7	7
Failure to Cut	6	6
Thermal Decomposition of Device	6	6
Material Fragmentation	6	6
Insufficient Information	5	5
Smoking	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Melted	4	4
Improper or Incorrect Procedure or Method	4	4
Overheating of Device	4	4
Temperature Problem	4	4
Fracture	3	3
Electrical /Electronic Property Problem	3	3
Material Frayed	2	2
Material Twisted/Bent	2	2
Material Integrity Problem	2	2
Defective Component	2	2
Torn Material	2	2
Crack	2	2
Device Handling Problem	2	2
Device Contamination with Chemical or Other Material	2	2
Fitting Problem	2	2
Detachment Of Device Component	2	2
Therapy Delivered to Incorrect Body Area	2	2
Unintended Movement	1	1
Physical Resistance/Sticking	1	1
Material Deformation	1	1
Arcing	1	1
Patient Device Interaction Problem	1	1
Out-Of-Box Failure	1	1
Separation Problem	1	1
Noise, Audible	1	1
Mechanical Problem	1	1
Material Rupture	1	1
Entrapment of Device	1	1
Device Disinfection Or Sterilization Issue	1	1
Dull, Blunt	1	1
Product Quality Problem	1	1
Device Operates Differently Than Expected	1	1
Unintended Electrical Shock	1	1
Difficult to Remove	1	1
Patient-Device Incompatibility	1	1
Material Disintegration	1	1
Misassembled	1	1
Contamination /Decontamination Problem	1	1
Retraction Problem	1	1
Metal Shedding Debris	1	1
Device Dislodged or Dislocated	1	1
Difficult to Open or Close	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
Partial thickness (Second Degree) Burn	7	7
Insufficient Information	7	7
Hemorrhage/Bleeding	6	6
Foreign Body In Patient	5	5
Device Embedded In Tissue or Plaque	4	4
No Information	3	3
No Patient Involvement	3	3
Injury	3	3
Electric Shock	2	2
Unspecified Reproductive System or Breast Problem	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Patient Problem/Medical Problem	1	1
No Code Available	1	1
Hormonal Imbalance	1	1
Abdominal Pain	1	1
Burn, Thermal	1	1
Laceration(s)	1	1
Liver Laceration(s)	1	1
Internal Organ Perforation	1	1
Pain	1	1
Perforation	1	1