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TPLC
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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
1. K212150
Exablate Prostate System
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
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