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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 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
44
44
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
363
363
Visual Prompts will not Clear
107
107
Display or Visual Feedback Problem
88
88
Connection Problem
43
43
Break
39
39
Mechanical Problem
37
37
Use of Device Problem
16
16
Mechanical Jam
12
12
Audible Prompt/Feedback Problem
12
12
No Flow
11
11
Output Problem
10
10
Material Twisted/Bent
10
10
Infusion or Flow Problem
10
10
Detachment of Device or Device Component
9
9
Failure to Prime
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
Insufficient Information
4
4
No Display/Image
3
3
Failure to Align
3
3
Failure to Disconnect
3
3
No Apparent Adverse Event
3
3
Difficult to Insert
2
2
Loose or Intermittent Connection
2
2
Failure to Power Up
2
2
Smoking
1
1
Fitting Problem
1
1
Corroded
1
1
Crack
1
1
Fluid/Blood Leak
1
1
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
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
337
337
Hemorrhage/Bleeding
207
207
Perforation
53
53
Urinary Retention
39
39
No Known Impact Or Consequence To Patient
24
24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
16
16
Urinary Tract Infection
13
13
Pulmonary Embolism
12
12
Urethral Stenosis/Stricture
11
11
Low Blood Pressure/ Hypotension
10
10
Sexual Dysfunction
10
10
Laceration(s)
8
8
Incontinence
7
7
Bowel Perforation
7
7
Hematoma
5
5
Hematuria
5
5
Cardiac Arrest
4
4
Sepsis
4
4
Urinary Incontinence
3
3
Thrombosis/Thrombus
3
3
Respiratory Arrest
3
3
Insufficient Information
3
3
Patient Problem/Medical Problem
3
3
Myocardial Infarction
3
3
Hyponatremia
2
2
Obstruction/Occlusion
2
2
Bacterial Infection
2
2
Dysuria
2
2
Embolism/Embolus
2
2
Sudden Cardiac Death
2
2
Unspecified Kidney or Urinary Problem
2
2
Stenosis
1
1
Ulcer
1
1
Anemia
1
1
Gastrointestinal Hemorrhage
1
1
Bradycardia
1
1
No Code Available
1
1
Transient Ischemic Attack
1
1
Urinary Frequency
1
1
Fasciitis
1
1
Erectile Dysfunction
1
1
Air Embolism
1
1
High Blood Pressure/ Hypertension
1
1
Pneumonia
1
1
Fistula
1
1
Chest Pain
1
1
Unspecified Infection
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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