TPLC - Total Product Life Cycle

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Device	system, suction, lipoplasty for removal
Regulation Description	Suction lipoplasty system.
Definition	A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring
Product Code	QPB
Regulation Number	878.5040
Device Class	2

Premarket Reviews
Manufacturer	Decision
APYX MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
BLACK & BLACK SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
CELLMYX
	SUBSTANTIALLY EQUIVALENT	1
LHBIOMED CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MICROAIRE SURGICAL INSTRUMENTS
	SUBSTANTIALLY EQUIVALENT	1
MICROAIRE SURGICAL INSTRUMENTS, LLC
	SUBSTANTIALLY EQUIVALENT	4
PUREGRAFT LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	28	28
Activation Failure	6	6
Break	5	5
Communication or Transmission Problem	3	3
Key or Button Unresponsive/not Working	3	3
Suction Problem	3	3
Suction Failure	2	2
Patient-Device Incompatibility	2	3
Insufficient Information	2	2
Smoking	2	2
Material Fragmentation	2	2
Material Twisted/Bent	2	2
Blocked Connection	2	2
Detachment of Device or Device Component	2	2
Excessive Heating	2	2
Connection Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Noise, Audible	2	2
No Display/Image	1	1
Output Problem	1	1
Energy Output Problem	1	1
Defective Device	1	1
Pumping Stopped	1	1
Battery Problem	1	1
Use of Device Problem	1	1
Decrease in Suction	1	1
Material Separation	1	1
Ambient Noise Problem	1	1
Failure to Conduct	1	1
Failure of Device to Self-Test	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	31	31
Burn(s)	23	23
Scar Tissue	9	9
Full thickness (Third Degree) Burn	3	3
Partial thickness (Second Degree) Burn	3	3
Necrosis	3	3
Pain	3	3
Erythema	3	3
Blister	3	3
Bruise/Contusion	2	2
Swelling/ Edema	2	2
Insufficient Information	2	2
Skin Discoloration	2	2
Inflammation	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Cardiac Arrest	1	1
Localized Skin Lesion	1	1
Anemia	1	1
Pleural Effusion	1	1
Septic Shock	1	1
Disseminated Intravascular Coagulation (DIC)	1	1
Ecchymosis	1	1
Bowel Perforation	1	1
Nausea	1	1
Hypoglycemia	1	1
Tachycardia	1	1
Anxiety	1	1
Unspecified Tissue Injury	1	2
Ulcer	1	1
Skin Tears	1	1
Skin Infection	1	1
Physical Asymmetry	1	1
No Consequences Or Impact To Patient	1	1
Deformity/ Disfigurement	1	1
Fibrosis	1	1
Low Blood Pressure/ Hypotension	1	1
Respiratory Failure	1	1
Tissue Breakdown	1	1
Superficial (First Degree) Burn	1	1
Pulmonary Embolism	1	1
Abdominal Pain	1	1
Distress	1	1
Lethargy	1	1
Skin Burning Sensation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	HUMAN MED AG	II	Feb-28-2025