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TPLC
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Device
fluid jet removal system
Regulation Description
Fluid jet system for prostate tissue removal.
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
2
1. K202961
AquaBeam Robotic System
2. K212835
AquaBeam Robotic System
3. K231024
AquaBeam Robotic System
PROCEPT BIOROBOTICS CORPORATION
SUBSTANTIALLY EQUIVALENT
3
1. K202961
AquaBeam Robotic System
2. K212835
AquaBeam Robotic System
3. K231024
AquaBeam Robotic System
MDR Year
MDR Reports
MDR Events
2020
85
85
2021
99
99
2022
174
174
2023
254
254
2024
309
309
2025
27
27
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
451
451
Visual Prompts will not Clear
185
185
Display or Visual Feedback Problem
88
88
Connection Problem
52
52
Break
43
43
Mechanical Problem
42
42
No Flow
18
18
Mechanical Jam
16
16
Failure to Prime
14
14
Infusion or Flow Problem
13
13
Audible Prompt/Feedback Problem
12
12
Use of Device Problem
12
12
Failure to Align
11
11
Material Twisted/Bent
10
10
Output Problem
10
10
Detachment of Device or Device Component
9
9
Suction Failure
8
8
Moisture Damage
8
8
Incomplete or Inadequate Connection
8
8
Poor Quality Image
8
8
Priming Problem
7
7
No Display/Image
6
6
Insufficient Information
5
5
Leak/Splash
4
4
Loose or Intermittent Connection
4
4
Failure to Power Up
3
3
Failure to Disconnect
3
3
Failure to Deliver
2
2
Difficult to Insert
2
2
Unintended Collision
1
1
Crack
1
1
Patient Device Interaction Problem
1
1
Complete Loss of Power
1
1
Corroded
1
1
Material Split, Cut or Torn
1
1
Pumping Problem
1
1
Positioning Problem
1
1
Material Integrity Problem
1
1
No Apparent Adverse Event
1
1
Dent in Material
1
1
Optical Distortion
1
1
Optical Problem
1
1
Deformation Due to Compressive Stress
1
1
Fitting Problem
1
1
Obstruction of Flow
1
1
Power Problem
1
1
Smoking
1
1
Material Deformation
1
1
Fluid/Blood Leak
1
1
Failure to Fire
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
469
469
Hemorrhage/Bleeding
215
215
Perforation
87
87
Urinary Retention
39
39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
22
22
Urethral Stenosis/Stricture
20
20
Low Blood Pressure/ Hypotension
19
19
Cardiac Arrest
17
17
Sexual Dysfunction
17
17
Pulmonary Embolism
15
15
Urinary Tract Infection
15
15
Laceration(s)
14
14
No Known Impact Or Consequence To Patient
11
11
Hematuria
9
9
Incontinence
8
8
Insufficient Information
8
8
Embolism/Embolus
6
6
Bowel Perforation
5
5
Sepsis
5
5
Bradycardia
3
3
Urinary Incontinence
3
3
Patient Problem/Medical Problem
3
3
Thrombosis/Thrombus
3
3
Respiratory Arrest
3
3
Unspecified Kidney or Urinary Problem
3
3
Obstruction/Occlusion
2
2
Bacterial Infection
2
2
Unspecified Infection
2
2
Dysuria
2
2
Hyponatremia
2
2
Fasciitis
1
1
Urinary Frequency
1
1
Ulcer
1
1
Stenosis
1
1
Rupture
1
1
Transient Ischemic Attack
1
1
Renal Failure
1
1
Pneumonia
1
1
Myocardial Infarction
1
1
Ischemia
1
1
Liver Failure
1
1
Gastrointestinal Hemorrhage
1
1
Aspiration Pneumonitis
1
1
Cancer
1
1
Swelling/ Edema
1
1
Erectile Dysfunction
1
1
Hypoxia
1
1
High Blood Pressure/ Hypertension
1
1
Fistula
1
1
Chest Pain
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
PROCEPT BIOROBOTICS CORPORATION
II
Aug-20-2021
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