Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
fluid jet removal system
Definition
The system is used for removal of prostate tissue with a fluid jet.
Product Code
PZP
Regulation Number
876.4350
Device Class
2
Premarket Reviews
Manufacturer
Decision
PROCEPT BIOROBOTICS CORPORATION
GRANTED
1
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2018
14
14
2019
70
70
2020
85
85
2021
99
99
2022
174
174
2023
254
254
2024
138
138
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
410
410
Visual Prompts will not Clear
142
142
Display or Visual Feedback Problem
88
88
Connection Problem
45
45
Break
40
40
Mechanical Problem
38
38
Use of Device Problem
16
16
Mechanical Jam
13
13
No Flow
12
12
Audible Prompt/Feedback Problem
12
12
Material Twisted/Bent
10
10
Output Problem
10
10
Infusion or Flow Problem
10
10
Failure to Prime
10
10
Detachment of Device or Device Component
9
9
Nonstandard Device
8
8
Suction Failure
8
8
Priming Problem
7
7
Incomplete or Inadequate Connection
7
7
Moisture Damage
5
5
Poor Quality Image
4
4
Leak/Splash
4
4
Failure to Align
4
4
Insufficient Information
4
4
No Apparent Adverse Event
3
3
Failure to Disconnect
3
3
Loose or Intermittent Connection
3
3
No Display/Image
3
3
Difficult to Insert
2
2
Failure to Power Up
2
2
Positioning Problem
1
1
Power Problem
1
1
Optical Distortion
1
1
Optical Problem
1
1
Deformation Due to Compressive Stress
1
1
Dent in Material
1
1
Material Deformation
1
1
Material Integrity Problem
1
1
Corroded
1
1
Crack
1
1
Fluid/Blood Leak
1
1
Unintended Collision
1
1
Smoking
1
1
Fitting Problem
1
1
Patient Device Interaction Problem
1
1
Complete Loss of Power
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
383
383
Hemorrhage/Bleeding
229
229
Perforation
63
63
Urinary Retention
42
42
No Known Impact Or Consequence To Patient
24
24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
19
19
Urethral Stenosis/Stricture
16
16
Urinary Tract Infection
13
13
Pulmonary Embolism
13
13
Low Blood Pressure/ Hypotension
12
12
Laceration(s)
12
12
Sexual Dysfunction
11
11
Incontinence
8
8
Cardiac Arrest
8
8
Bowel Perforation
7
7
Hematuria
6
6
Hematoma
5
5
Sepsis
4
4
Myocardial Infarction
3
3
Bradycardia
3
3
Patient Problem/Medical Problem
3
3
Thrombosis/Thrombus
3
3
Respiratory Arrest
3
3
Urinary Incontinence
3
3
Insufficient Information
3
3
Hyponatremia
2
2
Unspecified Kidney or Urinary Problem
2
2
Embolism/Embolus
2
2
Dysuria
2
2
Obstruction/Occlusion
2
2
Sudden Cardiac Death
2
2
Bacterial Infection
2
2
Air Embolism
1
1
Anemia
1
1
Chest Pain
1
1
Fistula
1
1
High Blood Pressure/ Hypertension
1
1
Unspecified Infection
1
1
Transient Ischemic Attack
1
1
Pneumonia
1
1
Stenosis
1
1
Ulcer
1
1
Urinary Frequency
1
1
Fasciitis
1
1
No Code Available
1
1
Gastrointestinal Hemorrhage
1
1
Erectile Dysfunction
1
1
Swelling/ Edema
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
PROCEPT BIOROBOTICS CORPORATION
II
Aug-20-2021
2
PROCEPT BIOROBOTICS CORPORATION
II
Apr-08-2019
-
-