TPLC - Total Product Life Cycle

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Device	transducer, ultrasonic, diagnostic
Regulation Description	Diagnostic ultrasonic transducer.
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
1. K211270 CIV-Clear cover
2. K222052 VitroPRO
3. K231783 VitroPRO
CIVCO MEDICAL SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
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	893	893
Break	118	118
Adverse Event Without Identified Device or Use Problem	75	75
Leak/Splash	68	68
Material Twisted/Bent	48	48
Fluid/Blood Leak	47	47
Material Deformation	45	45
Detachment of Device or Device Component	34	34
Deformation Due to Compressive Stress	34	34
No Display/Image	32	32
Defective Component	29	29
Material Split, Cut or Torn	28	28
Failure to Clean Adequately	25	25
Device Contamination with Body Fluid	21	21
Stretched	18	18
Entrapment of Device	18	18
Mechanical Problem	16	16
Material Integrity Problem	16	16
Mechanical Jam	15	15
Contamination /Decontamination Problem	13	13
Data Problem	13	13
Material Puncture/Hole	13	13
Material Separation	13	13
Defective Device	12	12
Output Problem	11	11
Contamination	11	11
No Apparent Adverse Event	11	11
Device Reprocessing Problem	9	9
Scratched Material	9	9
Improper or Incorrect Procedure or Method	9	9
Device Contamination with Chemical or Other Material	9	9
Crack	8	8
Nonstandard Device	7	7
Therapeutic or Diagnostic Output Failure	7	7
Patient Device Interaction Problem	6	6
Display or Visual Feedback Problem	6	6
Patient-Device Incompatibility	6	6
Positioning Problem	6	6
Microbial Contamination of Device	4	4
Material Perforation	4	4
Dent in Material	4	4
Image Display Error/Artifact	4	4
Failure to Advance	4	4
Application Program Freezes, Becomes Nonfunctional	4	4
Device Handling Problem	3	3
Insufficient Information	3	3
Gel Leak	3	3
Sharp Edges	3	3
Unable to Obtain Readings	3	3
Naturally Worn	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1444	1444
No Consequences Or Impact To Patient	76	76
No Known Impact Or Consequence To Patient	29	29
Insufficient Information	28	28
Pneumothorax	20	20
Hemorrhage/Bleeding	17	17
Foreign Body In Patient	16	16
No Patient Involvement	12	12
Bacterial Infection	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Unspecified Infection	5	5
Burn, Thermal	5	5
Perforation of Vessels	4	4
Pneumonia	4	4
Rash	4	4
Fever	4	4
Pancreatitis	3	3
Sepsis	3	3
Perforation of Esophagus	3	3
Pain	3	3
Chest Pain	3	3
Itching Sensation	3	3
Laceration(s) of Esophagus	3	3
Device Embedded In Tissue or Plaque	2	2
Urinary Tract Infection	2	2
Respiratory Failure	2	2
Fibrosis	2	2
Hypoxia	2	2
Fluid Discharge	2	2
Laceration(s)	2	2
Urinary Retention	2	2
Burning Sensation	2	2
Vaginal Mucosa Damage	2	2
Cardiac Arrest	2	2
Obstruction/Occlusion	2	2
Air Embolism	2	2
Patient Problem/Medical Problem	2	2
Ectopic Pregnancy	2	2
Electric Shock	2	2
Gastroesophageal Burn	2	2
Hemoptysis	2	2
Vascular Dissection	2	2
Necrosis	2	2
Decreased Appetite	1	1
Skin Burning Sensation	1	1
Fistula	1	1
Embolus	1	1
Low Oxygen Saturation	1	1
Abortion	1	1
Syncope/Fainting	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	ImaCor Inc.	II	Oct-25-2024
13	Lumenis, Inc.	I	Nov-04-2021
14	Mac Medical Supply Co Inc	I	Sep-17-2021
15	National Distribution & Contracting Inc	I	Oct-13-2021
16	North Coast Medical Inc	I	Sep-29-2021
17	Olympus Corporation of the Americas	II	May-05-2022
18	Olympus Corporation of the Americas	II	Nov-27-2020
19	Philips Ultrasound Inc	II	May-01-2020
20	Philips Ultrasound, Inc.	II	Sep-06-2023
21	Red Medical Supplies	I	Oct-14-2021
22	Scrip Inc	I	Nov-17-2021
23	Verathon, Inc.	II	Dec-03-2020