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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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
  SUBSTANTIALLY EQUIVALENT 2
PROCEPT BIOROBOTICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2020 85 85
2021 99 99
2022 174 174
2023 254 254
2024 309 309

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 430 430
Visual Prompts will not Clear 180 180
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
Use of Device Problem 12 12
Audible Prompt/Feedback Problem 12 12
Failure to Align 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
Poor Quality Image 8 8
Suction Failure 8 8
Moisture Damage 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 Disconnect 3 3
Failure to Power Up 3 3
Failure to Deliver 2 2
Difficult to Insert 2 2
Unintended Collision 1 1
Fluid/Blood Leak 1 1
Deformation Due to Compressive Stress 1 1
Corroded 1 1
Complete Loss of Power 1 1
Power Problem 1 1
No Apparent Adverse Event 1 1
Failure to Fire 1 1
Optical Problem 1 1
Material Deformation 1 1
Dent in Material 1 1
Patient Device Interaction Problem 1 1
Optical Distortion 1 1
Positioning Problem 1 1
Material Integrity Problem 1 1
Smoking 1 1
Pumping Problem 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 464 464
Hemorrhage/Bleeding 201 201
Perforation 81 81
Urinary Retention 39 39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Urethral Stenosis/Stricture 20 20
Low Blood Pressure/ Hypotension 17 17
Sexual Dysfunction 17 17
Cardiac Arrest 16 16
Urinary Tract Infection 15 15
Pulmonary Embolism 15 15
Laceration(s) 14 14
No Known Impact Or Consequence To Patient 11 11
Hematuria 8 8
Insufficient Information 8 8
Incontinence 8 8
Sepsis 5 5
Bowel Perforation 5 5
Embolism/Embolus 4 4
Patient Problem/Medical Problem 3 3
Respiratory Arrest 3 3
Urinary Incontinence 3 3
Bradycardia 3 3
Unspecified Kidney or Urinary Problem 3 3
Thrombosis/Thrombus 3 3
Bacterial Infection 2 2
Obstruction/Occlusion 2 2
Dysuria 2 2
Hyponatremia 2 2
Unspecified Infection 2 2
Transient Ischemic Attack 1 1
Rupture 1 1
Erectile Dysfunction 1 1
Chest Pain 1 1
Anemia 1 1
Ischemia 1 1
Pneumonia 1 1
Gastrointestinal Hemorrhage 1 1
Stenosis 1 1
Fasciitis 1 1
Swelling/ Edema 1 1
Renal Failure 1 1
Ulcer 1 1
Myocardial Infarction 1 1
Hypoxia 1 1
Stroke/CVA 1 1
Urinary Frequency 1 1
Liver Failure 1 1
Cancer 1 1
Air Embolism 1 1

Recalls
Manufacturer Recall Class Date Posted
1 PROCEPT BIOROBOTICS CORPORATION II Aug-20-2021
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