TPLC - Total Product Life Cycle

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Device	electrode, electrosurgical, active, urological
Regulation Description	Endoscopic electrosurgical unit and accessories.
Product Code	FAS
Regulation Number	876.4300
Device Class	2

Premarket Reviews
Manufacturer	Decision
CHIRURGIE INNOVATION
	SUBSTANTIALLY EQUIVALENT	1
DORNIER MEDTECH AMERICA INC (DMTA)
	SUBSTANTIALLY EQUIVALENT	1
DORNIER MEDTECH AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
LAMIDEY NOURY MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
MULTI4 MEDICAL AB
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS WINTER &IBE GMBH
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	602	607
Detachment of Device or Device Component	206	207
Material Fragmentation	89	90
Sparking	75	75
Material Twisted/Bent	64	64
Fracture	64	64
Melted	59	59
Mechanical Problem	55	55
Thermal Decomposition of Device	33	33
Adverse Event Without Identified Device or Use Problem	33	33
Material Deformation	32	32
Overheating of Device	24	24
Material Separation	19	19
Arcing	18	18
Crack	18	18
Insufficient Information	16	16
Excessive Heating	14	14
Electrical /Electronic Property Problem	12	12
Material Split, Cut or Torn	11	11
Defective Component	11	11
Unintended Electrical Shock	10	10
Output Problem	10	10
Material Disintegration	9	9
Defective Device	9	9
Energy Output Problem	8	8
Explosion	8	8
Fire	8	8
Material Integrity Problem	8	8
Arcing of Electrodes	8	8
Component Missing	8	8
Use of Device Problem	8	8
Smoking	7	7
Manufacturing, Packaging or Shipping Problem	7	7
Device Damaged Prior to Use	5	5
Electrical Shorting	5	5
Tear, Rip or Hole in Device Packaging	5	5
No Apparent Adverse Event	4	4
Communication or Transmission Problem	4	4
Delivered as Unsterile Product	4	4
Failure to Cut	4	4
Intermittent Loss of Power	4	4
Temperature Problem	4	4
Activation Failure	3	3
Failure to Conduct	3	3
Device Emits Odor	3	3
Improper or Incorrect Procedure or Method	3	3
Circuit Failure	3	3
Disconnection	3	3
Loose or Intermittent Connection	2	2
Corroded	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1041	1043
Insufficient Information	114	115
Foreign Body In Patient	92	95
Hemorrhage/Bleeding	24	24
Burn(s)	17	17
Electric Shock	11	11
Internal Organ Perforation	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Laceration(s)	7	7
Perforation	7	7
Superficial (First Degree) Burn	5	5
Pancreatitis	4	4
Rupture	3	3
Uterine Perforation	3	3
Device Embedded In Tissue or Plaque	3	3
Dysuria	2	2
Bowel Perforation	2	2
Increased Intra-Peritoneal Volume (IIPV)	2	2
Urinary Incontinence	2	2
Unspecified Gastrointestinal Problem	2	2
Twitching	2	2
Ecchymosis	2	2
Partial thickness (Second Degree) Burn	2	2
No Consequences Or Impact To Patient	2	2
Hematuria	1	1
Cyst(s)	1	1
Genital Bleeding	1	1
Adhesion(s)	1	1
Anemia	1	1
Blister	1	1
Movement Disorder	1	1
Gastrointestinal Hemorrhage	1	1
Swelling	1	1
No Patient Involvement	1	1
Unspecified Kidney or Urinary Problem	1	1
Hyperextension	1	1
Bradycardia	1	1
Asystole	1	1
Stenosis	1	1
Shaking/Tremors	1	1
Tachycardia	1	1
Unspecified Tissue Injury	1	1
Bronchospasm	1	1
Myocardial Infarction	1	1
Abdominal Pain	1	1
Full thickness (Third Degree) Burn	1	1
Skin Burning Sensation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Aomori Olympus Co., Ltd.	II	Feb-05-2021
2	Olympus Corporation of the Americas	II	Dec-15-2023
3	Olympus Corporation of the Americas	II	Aug-17-2023