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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
Regulation Description Fluid jet system for prostate tissue removal.
Definition The system is used for removal of prostate tissue with a fluid jet.
Product CodePZP
Regulation Number 876.4350
Device Class 2

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
Urinary Tract Infection 15 15
Pulmonary Embolism 15 15
Laceration(s) 14 14
No Known Impact Or Consequence To Patient 11 11
Hematuria 9 9
Insufficient Information 8 8
Incontinence 8 8
Embolism/Embolus 6 6
Sepsis 5 5
Bowel Perforation 5 5
Urinary Incontinence 3 3
Patient Problem/Medical Problem 3 3
Thrombosis/Thrombus 3 3
Respiratory Arrest 3 3
Bradycardia 3 3
Unspecified Kidney or Urinary Problem 3 3
Obstruction/Occlusion 2 2
Unspecified Infection 2 2
Bacterial Infection 2 2
Hyponatremia 2 2
Dysuria 2 2
Anemia 1 1
Air Embolism 1 1
Liver Failure 1 1
Stroke/CVA 1 1
Chest Pain 1 1
Fistula 1 1
Gastrointestinal Hemorrhage 1 1
High Blood Pressure/ Hypertension 1 1
Aspiration Pneumonitis 1 1
Hypoxia 1 1
Cancer 1 1
Erectile Dysfunction 1 1
Rupture 1 1
Swelling/ Edema 1 1
Transient Ischemic Attack 1 1
Renal Failure 1 1
Pneumonia 1 1
Stenosis 1 1
Ulcer 1 1
Urinary Frequency 1 1

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