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
BRYMILL CRYOGENIC SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
CRYOCONCEPTS LP
	SUBSTANTIALLY EQUIVALENT	5
CRYOSURGERY, INC.
	SUBSTANTIALLY EQUIVALENT	5
CSA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
DGI TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
ENDOCISION TECHNOLOGIES INC.
	SUBSTANTIALLY EQUIVALENT	1
ERBE ELEKTROMEDIZIN GMBH
	SUBSTANTIALLY EQUIVALENT	1
GALIL MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
HYGEA MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ICECURE MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL BRANDS LABORATORIES B.V.
	SUBSTANTIALLY EQUIVALENT	1
MEDILINK A/S
	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	3
PRONOVA LABORATORIES BV
	SUBSTANTIALLY EQUIVALENT	1
R2 TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
RECENS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
RECENSMEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	3
RECENSMEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
THE OTC LAB HEALTHCARE B.V.
	SUBSTANTIALLY EQUIVALENT	1
VARIAN MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	3
YOZMA BMTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	242	243
Thermal Decomposition of Device	112	112
Insufficient Cooling	89	89
Appropriate Term/Code Not Available	88	88
Gas/Air Leak	86	87
Defective Device	83	83
Leak/Splash	72	72
Break	56	56
Mechanical Problem	56	56
Defective Component	45	45
Insufficient Heating	44	44
Insufficient Information	35	35
Use of Device Problem	29	29
Output Problem	25	25
Temperature Problem	22	22
Material Twisted/Bent	18	18
Physical Resistance/Sticking	18	18
Noise, Audible	16	16
Therapeutic or Diagnostic Output Failure	14	16
Failure to Fire	13	13
Free or Unrestricted Flow	12	63
Crack	11	12
Material Separation	9	9
Loose or Intermittent Connection	9	9
Improper or Incorrect Procedure or Method	9	9
Explosion	9	9
Difficult to Remove	8	8
No Apparent Adverse Event	8	8
Fluid/Blood Leak	8	8
Expulsion	7	7
Device Alarm System	6	6
Gas Output Problem	6	6
Detachment of Device or Device Component	6	6
Burst Container or Vessel	6	6
Contamination	6	6
Material Deformation	6	6
Display or Visual Feedback Problem	5	5
Device Handling Problem	5	5
Fire	5	5
No Display/Image	5	5
Pressure Problem	5	5
Infusion or Flow Problem	5	5
Fracture	5	5
Material Rupture	4	4
Naturally Worn	4	4
Difficult to Open or Close	4	4
Excessive Cooling	4	4
Device Displays Incorrect Message	4	4
Mechanical Jam	4	4
Failure to Shut Off	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	451	500
Insufficient Information	126	134
Muscle Spasm(s)	71	71
No Consequences Or Impact To Patient	59	59
Burn(s)	49	49
Hemorrhage/Bleeding	43	43
No Known Impact Or Consequence To Patient	39	39
Fistula	32	32
Pain	31	31
Pneumothorax	30	30
Superficial (First Degree) Burn	19	19
Epistaxis	19	19
Necrosis	19	19
Partial thickness (Second Degree) Burn	18	18
Cramp(s) /Muscle Spasm(s)	18	18
Hematoma	18	18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	17	17
Pleural Effusion	17	17
No Code Available	16	16
Cryogenic Burn	16	20
Renal Failure	15	15
Unspecified Infection	14	14
Laceration(s)	14	14
Full thickness (Third Degree) Burn	13	13
Obstruction/Occlusion	13	13
Perforation	12	12
Dyspnea	10	10
Incontinence	10	10
Urinary Retention	10	10
Blood Loss	10	10
Arrhythmia	9	9
Respiratory Failure	9	9
Unspecified Tissue Injury	9	9
Cardiac Arrest	8	8
Caustic/Chemical Burns	8	9
Swelling/ Edema	8	8
Nerve Damage	8	8
Hematuria	8	8
Urinary Tract Infection	8	8
Discomfort	7	7
Fatigue	7	7
Foreign Body In Patient	7	7
Inflammation	6	6
Hemoptysis	6	6
Cancer	5	5
Abdominal Distention	5	5
Laceration(s) of Esophagus	5	5
Bowel Perforation	5	5
Perforation of Esophagus	5	5
Blister	5	7

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	Boston Scientific Corporation	II	Dec-22-2020
5	Boston Scientific Corporation	II	Oct-23-2020
6	Boston Scientific Corporation	II	Jul-21-2020
7	Icecure Medical Ltd	II	Sep-29-2023
8	New Medical Technologies Gmbh	II	Feb-05-2025
9	OraSure Technologies, Inc.	III	Sep-23-2020