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	31	31
Material Separation	13	13
Fracture	8	8
Mechanical Problem	7	7
Material Fragmentation	6	6
Torn Material	4	4
Difficult to Remove	3	3
Flare or Flash	2	2
Failure to Cut	2	2
Detachment of Device or Device Component	2	2
Device Operates Differently Than Expected	1	1
Electrical Shorting	1	1
Arcing of Electrodes	1	1
Defective Component	1	1
Separation Failure	1	1
Therapy Delivered to Incorrect Body Area	1	1
Detachment Of Device Component	1	1
Unintended Power Up	1	1
Entrapment of Device	1	1
Material Integrity Problem	1	1
Material Protrusion/Extrusion	1	1
Physical Property Issue	1	1
Therapeutic or Diagnostic Output Failure	1	1
No Apparent Adverse Event	1	1
Insufficient Information	1	1
Device Handling Problem	1	1
Excessive Heating	1	1
Bent	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	22	22
No Known Impact Or Consequence To Patient	14	14
Insufficient Information	10	10
No Clinical Signs, Symptoms or Conditions	9	9
Burn(s)	3	3
Foreign Body In Patient	3	3
Device Embedded In Tissue or Plaque	2	2
Fibrosis	1	1
No Information	1	1
Missing Value Reason	1	1
Patient Problem/Medical Problem	1	1
Partial thickness (Second Degree) Burn	1	1