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 Code	PZP
Regulation Number	876.4350
Device Class	2

Premarket Reviews
Manufacturer	Decision
PROCEPT BIOROBOTICS CORPORATION
	GRANTED	1
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	398	398
Visual Prompts will not Clear	132	132
Display or Visual Feedback Problem	88	88
Connection Problem	45	45
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	369	369
Hemorrhage/Bleeding	224	224
Perforation	58	58
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
Sexual Dysfunction	11	11
Laceration(s)	9	9
Incontinence	8	8
Cardiac Arrest	7	7
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

Recalls
Manufacturer		Recall Class	Date Posted
1	PROCEPT BIOROBOTICS CORPORATION	II	Aug-20-2021
2	PROCEPT BIOROBOTICS CORPORATION	II	Apr-08-2019