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