TPLC - Total Product Life Cycle

• Device: high intensity ultrasound system for prostate tissue ablation
• Definition: Prostate tissue ablation
• Product Code: PLP
• Regulation Number: 876.4340
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
EDAP TECHNOMED, INC.
	SUBSTANTIALLY EQUIVALENT	3
INSIGHTEC, INC
	SUBSTANTIALLY EQUIVALENT	1
INSIGHTEC, LTD.
	SUBSTANTIALLY EQUIVALENT	1
PROFOUND MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	1
PROFOUND MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	3
SONACARE MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
SONACARE MEDICAL, LLC.
	GRANTED	1

MDR Year	MDR Reports	MDR Events
2017	2	2
2019	2	2
2021	1	1
2022	6	6
2023	6	6
2024	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	12	12
Use of Device Problem	4	4
Inadequate or Insufficient Training	2	2
Insufficient Information	2	2
Device Handling Problem	2	2
Output Problem	1	1
Use of Incorrect Control/Treatment Settings	1	1
Electrical /Electronic Property Problem	1	1
Difficult to Insert	1	1
Output above Specifications	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Fistula	11	11
Nerve Damage	2	2
Urinary Retention	2	2
Hematuria	2	2
Constipation	2	2
No Clinical Signs, Symptoms or Conditions	2	2
Diarrhea	1	1
Urethral Stenosis/Stricture	1	1
Fibrosis	1	1
Disability	1	1
Obstruction/Occlusion	1	1
Sleep Dysfunction	1	1
Perforation	1	1
Scarring	1	1
Swelling	1	1
Swollen Lymph Nodes	1	1
Thrombus	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Edap Technomed Inc.	II	Oct-26-2017