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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 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 138 138

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 410 410
Visual Prompts will not Clear 142 142
Display or Visual Feedback Problem 88 88
Connection Problem 45 45
Break 40 40
Mechanical Problem 38 38
Use of Device Problem 16 16
Mechanical Jam 13 13
No Flow 12 12
Audible Prompt/Feedback Problem 12 12
Material Twisted/Bent 10 10
Output Problem 10 10
Infusion or Flow Problem 10 10
Failure to Prime 10 10
Detachment of Device or Device Component 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
Failure to Align 4 4
Insufficient Information 4 4
No Apparent Adverse Event 3 3
Failure to Disconnect 3 3
Loose or Intermittent Connection 3 3
No Display/Image 3 3
Difficult to Insert 2 2
Failure to Power Up 2 2
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
Corroded 1 1
Crack 1 1
Fluid/Blood Leak 1 1
Unintended Collision 1 1
Smoking 1 1
Fitting 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 383 383
Hemorrhage/Bleeding 229 229
Perforation 63 63
Urinary Retention 42 42
No Known Impact Or Consequence To Patient 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Urethral Stenosis/Stricture 16 16
Urinary Tract Infection 13 13
Pulmonary Embolism 13 13
Low Blood Pressure/ Hypotension 12 12
Laceration(s) 12 12
Sexual Dysfunction 11 11
Incontinence 8 8
Cardiac Arrest 8 8
Bowel Perforation 7 7
Hematuria 6 6
Hematoma 5 5
Sepsis 4 4
Myocardial Infarction 3 3
Bradycardia 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
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
Swelling/ Edema 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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