Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
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 Back to Search Results
Device fluid jet removal system
Definition The system is used for removal of prostate tissue with a fluid jet.
Product CodePZP
Regulation Number 876.4350
Device Class 2


Premarket Reviews
ManufacturerDecision
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
-
-