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
	SUBSTANTIALLY EQUIVALENT	1
PROCEPT BIOROBOTICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
	GRANTED	1

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