TPLC - Total Product Life Cycle

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Device	unit, cryosurgical, accessories
Regulation Description	Cryosurgical unit and accessories.
Product Code	GEH
Regulation Number	878.4350
Device Class	2

Premarket Reviews
Manufacturer	Decision
BIBAWO MEDICAL A/S
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC
	SUBSTANTIALLY EQUIVALENT	2
BOSTON SCIENTIFIC CORP
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CRYOCONCEPTS LP
	SUBSTANTIALLY EQUIVALENT	5
CRYOSURGERY, INC.
	SUBSTANTIALLY EQUIVALENT	5
DGI TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
ENDOCISION TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
FOCUSED CRYO, INC.
	SUBSTANTIALLY EQUIVALENT	1
HYGEA MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ICECURE MEDICAL , LTD.
	SUBSTANTIALLY EQUIVALENT	2
MEDICAL BRANDS LABORATORIES B.V.
	SUBSTANTIALLY EQUIVALENT	2
MEDILINK A/S
	SUBSTANTIALLY EQUIVALENT	1
MEDINICE S.A.
	SUBSTANTIALLY EQUIVALENT	1
MEDINUX (TIANJIN) TECHNOLOGIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDTECH PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
NUANCE MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
PENTAX OF AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	2
PRONOVA LABORATORIES BV
	SUBSTANTIALLY EQUIVALENT	1
RECENSMEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	6
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
THEOTCLAB HEALTHCARE B.V.
	SUBSTANTIALLY EQUIVALENT	2
VARIAN MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	188	188
Break	100	100
Thermal Decomposition of Device	87	87
Insufficient Cooling	83	83
Gas/Air Leak	82	82
Leak/Splash	69	69
Mechanical Problem	57	57
Defective Device	56	56
Material Rupture	52	52
Defective Component	41	41
Insufficient Information	40	40
Insufficient Heating	35	35
Output Problem	26	26
Noise, Audible	25	25
Use of Device Problem	24	24
Temperature Problem	21	21
Material Twisted/Bent	15	15
Free or Unrestricted Flow	13	66
Physical Resistance/Sticking	12	12
Explosion	12	12
Therapeutic or Diagnostic Output Failure	12	14
Appropriate Term/Code Not Available	11	11
Crack	10	10
Material Separation	9	9
Loose or Intermittent Connection	9	9
Improper or Incorrect Procedure or Method	9	9
No Apparent Adverse Event	8	8
Fire	7	7
Detachment of Device or Device Component	7	7
Fluid/Blood Leak	7	7
Expulsion	7	7
Difficult to Remove	7	7
Display or Visual Feedback Problem	6	6
Burst Container or Vessel	6	6
Contamination	6	6
Human-Device Interface Problem	6	6
Infusion or Flow Problem	5	5
Fracture	5	5
Device Handling Problem	5	5
Material Deformation	5	5
Nonstandard Device	5	5
Device Alarm System	5	5
Gas Output Problem	5	5
Pressure Problem	5	5
Naturally Worn	4	4
Difficult to Open or Close	4	4
No Display/Image	4	4
Use of Incorrect Control/Treatment Settings	4	4
Unintended Movement	3	3
No Pressure	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	506	558
Insufficient Information	127	136
Burn(s)	49	49
Hemorrhage/Bleeding	45	45
Pain	34	34
Pneumothorax	24	24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	20	20
Epistaxis	18	18
Partial thickness (Second Degree) Burn	18	18
Cryogenic Burn	17	20
Superficial (First Degree) Burn	17	17
Cramp(s) /Muscle Spasm(s)	13	13
Full thickness (Third Degree) Burn	13	13
Fistula	13	13
Perforation	12	12
Unspecified Tissue Injury	11	11
Renal Failure	11	11
Arrhythmia	10	10
Discomfort	9	9
Swelling/ Edema	9	9
Pulmonary Embolism	8	8
Laceration(s)	8	8
Pneumonia	7	7
Fatigue	7	7
Foreign Body In Patient	7	7
Cancer	7	7
Hearing Impairment	7	7
Caustic/Chemical Burns	7	7
Obstruction/Occlusion	7	7
Pleural Effusion	6	6
Urinary Retention	6	6
Hematuria	6	6
Tinnitus	6	6
Perforation of Esophagus	6	6
Air Embolism	6	6
Laceration(s) of Esophagus	6	6
Stroke/CVA	5	5
Cardiac Arrest	5	5
Abdominal Pain	5	5
Unspecified Infection	5	5
Numbness	4	4
Erythema	4	4
Erectile Dysfunction	4	4
Urethral Stenosis/Stricture	4	4
Blood Loss	4	4
Hematoma	4	4
Inflammation	4	4
Muscle Weakness	4	4
Hemoptysis	4	4
Loss of consciousness	4	4

Recalls
Manufacturer		Recall Class	Date Posted
1	AtriCure, Inc.	II	Jan-31-2024
2	Boston Scientific Corporation	II	Sep-11-2025
3	Boston Scientific Corporation	II	Apr-29-2025
4	Erbe USA Inc	I	Mar-20-2026
5	Icecure Medical Ltd	II	Sep-29-2023
6	New Medical Technologies Gmbh	II	Feb-05-2025