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 Code	PZP
Regulation Number	876.4350
Device Class	2

Premarket Reviews
Manufacturer	Decision
PROCEPT BIOROBOTICS
	SUBSTANTIALLY EQUIVALENT	3
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	727	727
Visual Prompts will not Clear	271	271
Display or Visual Feedback Problem	93	93
Connection Problem	74	74
Break	48	48
Mechanical Problem	47	47
No Flow	21	21
Mechanical Jam	19	19
Use of Device Problem	18	18
Failure to Prime	16	16
Infusion or Flow Problem	15	15
Failure to Align	13	13
Audible Prompt/Feedback Problem	12	12
No Display/Image	10	10
Output Problem	10	10
Incomplete or Inadequate Connection	10	10
Poor Quality Image	10	10
Material Twisted/Bent	10	10
Firing Problem	9	9
Priming Problem	9	9
Detachment of Device or Device Component	9	9
Failure to Power Up	9	9
Suction Failure	8	8
Nonstandard Device	8	8
Moisture Damage	8	8
Loose or Intermittent Connection	6	6
Device Damaged Prior to Use	6	6
Insufficient Information	6	6
Leak/Splash	4	4
Activation Failure	4	4
No Apparent Adverse Event	4	4
Failure to Deliver	4	4
Failure to Disconnect	3	3
Patient Device Interaction Problem	3	3
Difficult to Insert	2	2
Therapeutic or Diagnostic Output Failure	2	2
Failure to Fire	2	2
Power Problem	2	2
Appropriate Term/Code Not Available	2	2
Material Integrity Problem	2	2
Complete Loss of Power	2	2
Crack	2	2
Fluid/Blood Leak	2	2
Noise, Audible	2	2
Obstruction of Flow	1	1
Dent in Material	1	1
Optical Distortion	1	1
Mechanics Altered	1	1
Calibration Problem	1	1
Material Deformation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	626	626
Hemorrhage/Bleeding	372	372
Perforation	161	161
Urinary Retention	47	47
Cardiac Arrest	29	29
Low Blood Pressure/ Hypotension	27	27
Pulmonary Embolism	25	25
Urethral Stenosis/Stricture	25	25
Laceration(s)	24	24
No Known Impact Or Consequence To Patient	24	24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	23	23
Sexual Dysfunction	20	20
Urinary Tract Infection	17	17
Hematuria	11	11
Embolism/Embolus	11	11
Incontinence	10	10
Insufficient Information	8	8
Sepsis	7	7
Bowel Perforation	7	7
Urinary Incontinence	6	6
Myocardial Infarction	5	5
Hematoma	5	5
Unspecified Infection	4	4
Respiratory Arrest	4	4
Bradycardia	4	4
Unspecified Kidney or Urinary Problem	4	4
Patient Problem/Medical Problem	3	3
Bacterial Infection	3	3
Hyponatremia	3	3
Erectile Dysfunction	3	3
Thrombosis/Thrombus	3	3
Sudden Cardiac Death	2	2
Obstruction/Occlusion	2	2
Dysuria	2	2
Stroke/CVA	2	2
Rupture	1	1
Atrial Fibrillation	1	1
Transient Ischemic Attack	1	1
Anemia	1	1
Ischemia	1	1
Cyst(s)	1	1
Chest Pain	1	1
Aspiration/Inhalation	1	1
Gastrointestinal Hemorrhage	1	1
Dehydration	1	1
Scar Tissue	1	1
No Code Available	1	1
Pneumonia	1	1
Renal Failure	1	1
Stenosis	1	1

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