TPLC - Total Product Life Cycle

• Device: high intensity ultrasound system for prostate tissue ablation
• Regulation Description: 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	1
INSIGHTEC, INC.
	SUBSTANTIALLY EQUIVALENT	1
INSIGHTEC, LTD.
	SUBSTANTIALLY EQUIVALENT	1
PROFOUND MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3

MDR Year	MDR Reports	MDR Events
2021	1	1
2022	6	6
2023	6	6
2024	10	10
2025	2	2
2026	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	16	16
Use of Device Problem	5	5
Insufficient Information	2	2
Device Handling Problem	2	2
Inadequate or Insufficient Training	2	2
Device-Device Incompatibility	1	1
Inadequate Instructions for Non-Healthcare Professional	1	1
No Display/Image	1	1
Output Problem	1	1
Output above Specifications	1	1
Difficult to Insert	1	1
Use of Incorrect Control/Treatment Settings	1	1
Device Dislodged or Dislocated	1	1
Electrical /Electronic Property Problem	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Fistula	17	17
No Clinical Signs, Symptoms or Conditions	2	2
Hematuria	2	2
Fibrosis	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Urinary Incontinence	1	1
Perforation	1	1
Urethral Stenosis/Stricture	1	1
Erectile Dysfunction	1	1
Nerve Damage	1	1
Urinary Retention	1	1
Cancer	1	1