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TPLC
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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
SUBSTANTIALLY EQUIVALENT
1
PROCEPT BIOROBOTICS CORPORATION
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2019
70
70
2020
85
85
2021
99
99
2022
174
174
2023
254
254
2024
224
224
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
441
441
Visual Prompts will not Clear
160
160
Display or Visual Feedback Problem
88
88
Connection Problem
50
50
Break
41
41
Mechanical Problem
40
40
No Flow
17
17
Mechanical Jam
15
15
Use of Device Problem
15
15
Infusion or Flow Problem
13
13
Audible Prompt/Feedback Problem
12
12
Failure to Prime
11
11
Output Problem
10
10
Material Twisted/Bent
10
10
Detachment of Device or Device Component
9
9
Incomplete or Inadequate Connection
8
8
Suction Failure
8
8
Nonstandard Device
8
8
Moisture Damage
7
7
Priming Problem
7
7
Failure to Align
7
7
No Display/Image
5
5
Leak/Splash
4
4
Poor Quality Image
4
4
Insufficient Information
4
4
Loose or Intermittent Connection
4
4
Failure to Disconnect
3
3
Failure to Power Up
3
3
Difficult to Insert
2
2
No Apparent Adverse Event
2
2
Deformation Due to Compressive Stress
1
1
Corroded
1
1
Complete Loss of Power
1
1
Fluid/Blood Leak
1
1
Unintended Collision
1
1
Power Problem
1
1
Material Deformation
1
1
Optical Problem
1
1
Dent in Material
1
1
Patient Device Interaction Problem
1
1
Failure to Deliver
1
1
Optical Distortion
1
1
Material Integrity Problem
1
1
Positioning Problem
1
1
Smoking
1
1
Crack
1
1
Material Split, Cut or Torn
1
1
Fitting Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
426
426
Hemorrhage/Bleeding
231
231
Perforation
70
70
Urinary Retention
42
42
No Known Impact Or Consequence To Patient
23
23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
21
21
Urethral Stenosis/Stricture
20
20
Low Blood Pressure/ Hypotension
16
16
Pulmonary Embolism
15
15
Sexual Dysfunction
15
15
Urinary Tract Infection
14
14
Laceration(s)
14
14
Cardiac Arrest
13
13
Incontinence
8
8
Hematuria
7
7
Bowel Perforation
6
6
Sepsis
5
5
Hematoma
5
5
Insufficient Information
4
4
Patient Problem/Medical Problem
3
3
Respiratory Arrest
3
3
Urinary Incontinence
3
3
Myocardial Infarction
3
3
Embolism/Embolus
3
3
Bradycardia
3
3
Unspecified Kidney or Urinary Problem
3
3
Thrombosis/Thrombus
3
3
Bacterial Infection
2
2
Sudden Cardiac Death
2
2
Obstruction/Occlusion
2
2
Dysuria
2
2
Hyponatremia
2
2
Unspecified Infection
2
2
Chest Pain
1
1
Erectile Dysfunction
1
1
Transient Ischemic Attack
1
1
Anemia
1
1
Pneumonia
1
1
Stenosis
1
1
Fasciitis
1
1
Swelling/ Edema
1
1
Gastrointestinal Hemorrhage
1
1
Ulcer
1
1
Stroke/CVA
1
1
Urinary Frequency
1
1
Liver Failure
1
1
Cancer
1
1
Air Embolism
1
1
High Blood Pressure/ Hypertension
1
1
Fistula
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
PROCEPT BIOROBOTICS CORPORATION
II
Aug-20-2021
2
PROCEPT BIOROBOTICS CORPORATION
II
Apr-08-2019
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