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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
95
95
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
388
388
Visual Prompts will not Clear
128
128
Display or Visual Feedback Problem
88
88
Connection Problem
44
44
Break
39
39
Mechanical Problem
37
37
Use of Device Problem
16
16
Mechanical Jam
13
13
Audible Prompt/Feedback Problem
12
12
No Flow
11
11
Material Twisted/Bent
10
10
Output Problem
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 Apparent Adverse Event
3
3
Loose or Intermittent Connection
3
3
No Display/Image
3
3
Failure to Align
3
3
Failure to Disconnect
3
3
Failure to Power Up
2
2
Difficult to Insert
2
2
Corroded
1
1
Crack
1
1
Fluid/Blood Leak
1
1
Unintended Collision
1
1
Smoking
1
1
Fitting Problem
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
362
362
Hemorrhage/Bleeding
220
220
Perforation
57
57
Urinary Retention
39
39
No Known Impact Or Consequence To Patient
24
24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
18
18
Urethral Stenosis/Stricture
14
14
Urinary Tract Infection
13
13
Pulmonary Embolism
13
13
Low Blood Pressure/ Hypotension
11
11
Sexual Dysfunction
11
11
Laceration(s)
9
9
Incontinence
8
8
Bowel Perforation
7
7
Hematuria
6
6
Cardiac Arrest
6
6
Hematoma
5
5
Sepsis
4
4
Myocardial Infarction
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
Bradycardia
1
1
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
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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