TPLC - Total Product Life Cycle

show TPLC since

Device	coagulator-cutter, endoscopic, bipolar (and accessories)
Product Code	HIN
Regulation Number	884.4150
Device Class	2

Premarket Reviews
Manufacturer	Decision
ETHICON, INC.
	SUBSTANTIALLY EQUIVALENT	1
GYRUS ACMI, INC.
	SUBSTANTIALLY EQUIVALENT	2
KARL STORZ ENDOSCOPY-AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
LINA MEDICAL APS
	SUBSTANTIALLY EQUIVALENT	1
MECTRA LABS, INC.
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS WINTER & IBE GMBH
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	34	34
Material Separation	13	13
Material Fragmentation	9	9
Fracture	8	8
Mechanical Problem	7	7
Detachment of Device or Device Component	5	5
Torn Material	4	4
Difficult to Remove	3	3
Excessive Heating	3	3
Flare or Flash	2	2
Failure to Cut	2	2
Arcing	2	2
Entrapment of Device	1	1
Crack	1	1
Unintended Power Up	1	1
Physical Property Issue	1	1
Separation Failure	1	1
Insufficient Information	1	1
Defective Component	1	1
Material Integrity Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Bent	1	1
Device Handling Problem	1	1
Electrical Shorting	1	1
Material Protrusion/Extrusion	1	1
No Apparent Adverse Event	1	1
Device Operates Differently Than Expected	1	1
Detachment Of Device Component	1	1
Therapy Delivered to Incorrect Body Area	1	1
Arcing of Electrodes	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	22	22
No Clinical Signs, Symptoms or Conditions	14	14
No Known Impact Or Consequence To Patient	14	14
Insufficient Information	11	11
Foreign Body In Patient	6	6
Superficial (First Degree) Burn	4	4
Burn(s)	3	3
Device Embedded In Tissue or Plaque	2	2
Patient Problem/Medical Problem	1	1
No Information	1	1
Missing Value Reason	1	1
Partial thickness (Second Degree) Burn	1	1
Fibrosis	1	1