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
Thermal Decomposition of Device	6	6
Material Fragmentation	6	6
Failure to Cut	6	6
Adverse Event Without Identified Device or Use Problem	5	5
Insufficient Information	5	5
Smoking	5	5
Overheating of Device	4	4
Improper or Incorrect Procedure or Method	4	4
Melted	4	4
Temperature Problem	4	4
Fracture	3	3
Electrical /Electronic Property Problem	3	3
Detachment Of Device Component	2	2
Crack	2	2
Material Frayed	2	2
Therapy Delivered to Incorrect Body Area	2	2
Fitting Problem	2	2
Defective Component	2	2
Device Contamination with Chemical or Other Material	2	2
Torn Material	2	2
Device Handling Problem	2	2
Material Integrity Problem	2	2
Material Twisted/Bent	2	2
Noise, Audible	1	1
Patient Device Interaction Problem	1	1
Physical Resistance/Sticking	1	1
Unintended Electrical Shock	1	1
Separation Problem	1	1
Unintended Movement	1	1
Material Deformation	1	1
Patient-Device Incompatibility	1	1
Contamination /Decontamination Problem	1	1
Device Disinfection Or Sterilization Issue	1	1
Device Operates Differently Than Expected	1	1
Difficult to Open or Close	1	1
Device Dislodged or Dislocated	1	1
Out-Of-Box Failure	1	1
Dull, Blunt	1	1
Arcing	1	1
Product Quality Problem	1	1
Metal Shedding Debris	1	1
Difficult to Remove	1	1
Retraction Problem	1	1
Material Rupture	1	1
Mechanical Problem	1	1
Misassembled	1	1
Material Disintegration	1	1
Entrapment of Device	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	35	35
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