TPLC - Total Product Life Cycle

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Device	electrode, electrosurgical, active, urological
Product Code	FAS
Regulation Number	876.4300
Device Class	2

Premarket Reviews
Manufacturer	Decision
CHIRURGIE INNOVATION
	SUBSTANTIALLY EQUIVALENT	2
DORNIER MEDTECH AMERICA INC.
	SUBSTANTIALLY EQUIVALENT	1
GYRUS ACMI, INC.
	SUBSTANTIALLY EQUIVALENT	2
LAMIDEY NOURY MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
MODERN MEDICAL EQUIPMENT MFG., LTD.
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS WINTER & IBE GMBH
	SUBSTANTIALLY EQUIVALENT	6
OMNITECH SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	706	706
Detachment of Device or Device Component	149	149
Material Fragmentation	136	136
Fracture	118	118
Mechanical Problem	107	107
Sparking	76	76
Detachment Of Device Component	55	55
Adverse Event Without Identified Device or Use Problem	50	50
Material Separation	39	39
Component Falling	30	30
Melted	28	28
Thermal Decomposition of Device	27	27
Material Twisted/Bent	25	25
Crack	20	20
Overheating of Device	19	19
Fire	17	17
Material Disintegration	16	16
Insufficient Information	15	15
Arcing of Electrodes	14	14
Component Missing	14	14
Material Deformation	13	13
Arcing	13	13
Defective Component	12	12
Device Or Device Fragments Location Unknown	11	11
Smoking	11	11
Material Split, Cut or Torn	10	10
Output Problem	10	10
Electrical Shorting	8	8
Charred	8	8
Electrical /Electronic Property Problem	8	8
Defective Device	7	7
Improper or Incorrect Procedure or Method	7	7
Material Integrity Problem	6	6
Failure to Cut	6	6
Device Operates Differently Than Expected	6	6
Use of Incorrect Control/Treatment Settings	5	5
Unintended Electrical Shock	5	5
Excessive Heating	5	5
Temperature Problem	4	4
Device Contamination with Chemical or Other Material	4	4
No Apparent Adverse Event	4	4
Device Damaged by Another Device	4	4
Peeled/Delaminated	4	4
Electrical Power Problem	4	4
Intermittent Loss of Power	4	4
Product Quality Problem	3	3
Explosion	3	3
Bent	3	3
Connection Problem	3	3
Disconnection	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	583	583
No Known Impact Or Consequence To Patient	205	205
No Consequences Or Impact To Patient	191	191
Foreign Body In Patient	115	115
Insufficient Information	81	81
Device Embedded In Tissue or Plaque	23	23
Hemorrhage/Bleeding	23	23
Burn(s)	20	20
Internal Organ Perforation	16	16
Perforation	13	13
No Information	12	12
Electric Shock	11	11
No Patient Involvement	8	8
Injury	5	5
Laceration(s)	4	4
Burn, Thermal	4	4
No Code Available	4	4
Pancreatitis	4	4
Bowel Perforation	3	3
Unspecified Infection	3	3
Blood Loss	3	3
Rupture	3	3
Death	3	3
Stenosis	3	3
Hematuria	2	2
Urinary Incontinence	2	2
Unspecified Gastrointestinal Problem	2	2
Uterine Perforation	2	2
Fever	2	2
Twitching	2	2
Unspecified Tissue Injury	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Ecchymosis	2	2
Skin Burning Sensation	1	1
Abdominal Pain	1	1
Full thickness (Third Degree) Burn	1	1
Constipation	1	1
Patient Problem/Medical Problem	1	1
Myocardial Infarction	1	1
Tissue Damage	1	1
Ulcer	1	1
Tachycardia	1	1
Shaking/Tremors	1	1
Shock	1	1
Asystole	1	1
Bradycardia	1	1
Abscess	1	1
Hyperextension	1	1
Unspecified Kidney or Urinary Problem	1	1
Pain	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Aomori Olympus Co., Ltd.	II	Feb-05-2021
2	C.R. Bard, Inc.	II	Nov-16-2016
3	Gyrus Acmi, Incorporated	II	May-29-2018
4	Olympus Corporation of the Americas	II	Dec-15-2023
5	Olympus Corporation of the Americas	II	Aug-17-2023
6	Olympus Corporation of the Americas	II	Dec-14-2016