TPLC - Total Product Life Cycle

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Device	transducer, ultrasonic, diagnostic
Product Code	ITX
Regulation Number	892.1570
Device Class	2

Premarket Reviews
Manufacturer	Decision
ADVANCE MEDICAL DESIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CIVCO MEDICAL INSTRUMENTS CO., INC.
	SUBSTANTIALLY EQUIVALENT	3
CIVCO MEDICAL SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	2
EXACT MEDICAL MANUFACTURING
	SUBSTANTIALLY EQUIVALENT	2
FUJIFILM HEALTHCARE AMERICAS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS,
	SUBSTANTIALLY EQUIVALENT	1
GLOBAL PROTECTION CORP.
	SUBSTANTIALLY EQUIVALENT	1
HONY MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
HUNTLEIGH HEALTHCARE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
MEDXPRESS.PRO
	SUBSTANTIALLY EQUIVALENT	1
PARKER LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
VITROLIFE SWEDEN AB
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Poor Quality Image	570	570
Adverse Event Without Identified Device or Use Problem	97	97
Break	93	93
Leak/Splash	50	50
Fluid/Blood Leak	48	48
No Display/Image	34	34
Defective Component	31	31
Material Twisted/Bent	27	27
Material Deformation	27	27
Detachment of Device or Device Component	24	24
Failure to Clean Adequately	20	20
Deformation Due to Compressive Stress	20	20
Mechanical Problem	18	18
Material Split, Cut or Torn	18	18
Device Contamination with Body Fluid	17	17
Mechanical Jam	15	15
Entrapment of Device	14	14
Material Separation	12	12
Therapeutic or Diagnostic Output Failure	12	12
Material Puncture/Hole	12	12
Data Problem	11	11
Defective Device	11	11
Output Problem	11	11
Device Contamination with Chemical or Other Material	10	10
Contamination /Decontamination Problem	10	10
Material Integrity Problem	10	10
Stretched	10	10
Contamination	10	10
Display or Visual Feedback Problem	10	10
Improper or Incorrect Procedure or Method	9	9
No Apparent Adverse Event	9	9
Image Display Error/Artifact	8	8
Nonstandard Device	7	7
Device Reprocessing Problem	7	7
Positioning Problem	6	6
Patient Device Interaction Problem	6	6
Crack	6	6
Patient-Device Incompatibility	6	6
Temperature Problem	5	5
Failure to Advance	4	4
Application Program Freezes, Becomes Nonfunctional	4	4
Microbial Contamination of Device	4	4
Scratched Material	4	4
Loss of Power	3	3
Gel Leak	3	3
Physical Resistance/Sticking	3	3
Device Displays Incorrect Message	3	3
Overheating of Device	3	3
Unable to Obtain Readings	3	3
Material Perforation	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	928	928
No Consequences Or Impact To Patient	109	109
No Known Impact Or Consequence To Patient	82	82
Insufficient Information	27	27
Pneumothorax	22	22
No Patient Involvement	19	19
Hemorrhage/Bleeding	17	17
Foreign Body In Patient	15	15
Bacterial Infection	11	11
Stenosis	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Perforation of Esophagus	7	7
Injury	6	6
Unspecified Infection	6	6
Burn, Thermal	5	5
Rash	4	4
Pneumonia	4	4
Perforation of Vessels	4	4
Chest Pain	4	4
Fever	4	4
Laceration(s) of Esophagus	4	4
Patient Problem/Medical Problem	3	3
Perforation	3	3
Pancreatitis	3	3
Pain	3	3
No Code Available	3	3
Sepsis	3	3
Dyspnea	2	2
Burning Sensation	2	2
Urinary Retention	2	2
Vaginal Mucosa Damage	2	2
Fluid Discharge	2	2
Cardiac Arrest	2	2
Gastroesophageal Burn	2	2
Air Embolism	2	2
Inflammation	2	2
Fibrosis	2	2
Electric Shock	2	2
Itching Sensation	2	2
Respiratory Failure	2	2
Device Embedded In Tissue or Plaque	2	2
Hemoptysis	2	2
Obstruction/Occlusion	2	2
Hypoxia	2	2
Urinary Tract Infection	2	2
Necrosis	2	2
Vascular Dissection	1	1
Taste Disorder	1	1
Headache	1	1
Blurred Vision	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	AMTEC SALES Inc	I	Sep-22-2021
2	Accelerated Care Plus Corporation	I	Sep-25-2021
3	Advance Medical Designs, Inc.	II	Sep-09-2023
4	Aesthetics Systems Usa Inc	I	Oct-06-2021
5	Aizu Olympus Co., Ltd.	II	Nov-17-2023
6	Athena Medical Products Inc	I	Sep-09-2021
7	DJO, LLC	I	Oct-05-2021
8	Exact Medical Manufacturing, Inc.	II	Jun-21-2021
9	GE Medical Systems, LLC	II	Dec-22-2022
10	Hitachi Medical Systems America Inc	II	Feb-20-2020
11	Huntleigh Healthcare Ltd.	II	Apr-20-2022
12	Lumenis, Inc.	I	Nov-04-2021
13	Mac Medical Supply Co Inc	I	Sep-17-2021
14	National Distribution & Contracting Inc	I	Oct-13-2021
15	North Coast Medical Inc	I	Sep-29-2021
16	Olympus Corporation of the Americas	II	May-05-2022
17	Olympus Corporation of the Americas	II	Nov-27-2020
18	Philips Ultrasound Inc	II	May-01-2020
19	Philips Ultrasound, Inc.	II	Sep-06-2023
20	Red Medical Supplies	I	Oct-14-2021
21	Scrip Inc	I	Nov-17-2021
22	Verathon, Inc.	II	Dec-03-2020