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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 1
PROCEPT BIOROBOTICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
  GRANTED 1

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 224 224

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 453 453
Visual Prompts will not Clear 160 160
Display or Visual Feedback Problem 88 88
Connection Problem 50 50
Break 41 41
Mechanical Problem 40 40
No Flow 17 17
Use of Device Problem 16 16
Mechanical Jam 15 15
Infusion or Flow Problem 13 13
Audible Prompt/Feedback Problem 12 12
Failure to Prime 11 11
Material Twisted/Bent 10 10
Output Problem 10 10
Detachment of Device or Device Component 9 9
Incomplete or Inadequate Connection 8 8
Suction Failure 8 8
Nonstandard Device 8 8
Failure to Align 7 7
Moisture Damage 7 7
Priming Problem 7 7
No Display/Image 5 5
Insufficient Information 4 4
Loose or Intermittent Connection 4 4
Poor Quality Image 4 4
Leak/Splash 4 4
No Apparent Adverse Event 3 3
Failure to Disconnect 3 3
Failure to Power Up 3 3
Difficult to Insert 2 2
Complete Loss of Power 1 1
Material Integrity Problem 1 1
Smoking 1 1
Material Deformation 1 1
Optical Problem 1 1
Power Problem 1 1
Positioning Problem 1 1
Corroded 1 1
Crack 1 1
Deformation Due to Compressive Stress 1 1
Optical Distortion 1 1
Patient Device Interaction Problem 1 1
Failure to Deliver 1 1
Material Split, Cut or Torn 1 1
Dent in Material 1 1
Fitting Problem 1 1
Unintended Collision 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 426 426
Hemorrhage/Bleeding 242 242
Perforation 70 70
Urinary Retention 42 42
No Known Impact Or Consequence To Patient 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 21 21
Urethral Stenosis/Stricture 20 20
Low Blood Pressure/ Hypotension 16 16
Pulmonary Embolism 15 15
Sexual Dysfunction 15 15
Urinary Tract Infection 14 14
Laceration(s) 14 14
Cardiac Arrest 13 13
Incontinence 8 8
Hematuria 7 7
Bowel Perforation 7 7
Sepsis 5 5
Hematoma 5 5
Insufficient Information 4 4
Patient Problem/Medical Problem 3 3
Myocardial Infarction 3 3
Respiratory Arrest 3 3
Urinary Incontinence 3 3
Bradycardia 3 3
Embolism/Embolus 3 3
Unspecified Kidney or Urinary Problem 3 3
Thrombosis/Thrombus 3 3
Bacterial Infection 2 2
Sudden Cardiac Death 2 2
Obstruction/Occlusion 2 2
Dysuria 2 2
Hyponatremia 2 2
Unspecified Infection 2 2
Erectile Dysfunction 1 1
Transient Ischemic Attack 1 1
Chest Pain 1 1
Anemia 1 1
Gastrointestinal Hemorrhage 1 1
Pneumonia 1 1
No Code Available 1 1
Stenosis 1 1
Fasciitis 1 1
Swelling/ Edema 1 1
Ulcer 1 1
Stroke/CVA 1 1
Liver Failure 1 1
Urinary Frequency 1 1
Cancer 1 1
High Blood Pressure/ Hypertension 1 1
Air Embolism 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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