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	663	664
Detachment of Device or Device Component	227	228
Material Fragmentation	97	98
Sparking	83	83
Material Twisted/Bent	81	81
Fracture	76	76
Melted	74	74
Mechanical Problem	55	55
Material Deformation	40	40
Thermal Decomposition of Device	34	34
Adverse Event Without Identified Device or Use Problem	33	33
Overheating of Device	27	27
Arcing	19	19
Material Separation	19	19
Crack	18	18
Excessive Heating	17	17
Insufficient Device Problem Information	17	17
Electrical /Electronic Property Problem	15	15
Defective Component	10	10
Unintended Electrical Shock	10	10
Material Split, Cut or Torn	10	10
Arcing of Electrodes	9	9
Material Disintegration	9	9
Energy Output Problem	9	9
Fire	9	9
Output Problem	9	9
Use of Device Problem	8	8
Explosion	8	8
Material Integrity Problem	8	8
Smoking	7	7
Manufacturing, Packaging or Shipping Problem	7	7
Defective Device	6	6
Component Missing	6	6
Tear, Rip or Hole in Device Packaging	5	5
Device Damaged Prior to Use	5	5
Activation Failure	5	5
No Apparent Adverse Event	5	5
Flare or Flash	5	5
Electrical Shorting	5	5
Failure to Cut	4	4
Delivered as Unsterile Product	4	4
Temperature Problem	4	4
Communication or Transmission Problem	4	4
Intermittent Loss of Power	4	4
Device Emits Odor	3	3
Degraded	3	3
Device Damaged Prior to Receipt by User	3	3
Device Handling Problem	3	3
Circuit Failure	3	3
Improper or Incorrect Procedure or Method	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1207	1209
Insufficient Information	120	121
Foreign Body In Patient	100	103
Hemorrhage/Blood Loss/Bleeding	25	25
Burn(s)	19	19
Electric Shock	11	11
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	9	9
Internal Organ Perforation	8	8
Perforation	8	8
Laceration(s)	7	7
Uterine Perforation	5	5
Superficial (First Degree) Burn	5	5
Pancreatitis	4	4
Bowel Perforation	4	4
Device Embedded In Tissue or Plaque	3	3
Rupture	3	3
No Consequences Or Impact To Patient	2	2
Ecchymosis	2	2
Twitching	2	2
Partial thickness (Second Degree) Burn	2	2
Unintended Radiation Exposure	2	2
Dysuria	2	2
Urinary Incontinence	2	2
Unspecified Gastrointestinal Problem	2	2
Increased Intra-Peritoneal Volume (IIPV)	2	2
Tachycardia	1	1
Myocardial Infarction	1	1
Abdominal Pain	1	1
Blister	1	1
Anemia	1	1
Bone Cement Implantation Syndrome	1	1
Non-malignant Neoplasm	1	1
Hyperextension	1	1
Stenosis	1	1
Shaking/Tremors	1	1
Bradycardia	1	1
Hematuria	1	1
Genital Bleeding	1	1
Bronchospasm	1	1
Pulmonary Embolism	1	1
No Patient Involvement	1	1
Movement Disorder	1	1
Full thickness (Third Degree) Burn	1	1
Skin Burning Sensation	1	1
Unspecified Kidney or Urinary Problem	1	1
Asystole	1	1
Adhesion(s)	1	1
Cyst(s)	1	1
Gastrointestinal Hemorrhage	1	1
Swelling	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