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
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	870	870
Break	114	114
Adverse Event Without Identified Device or Use Problem	75	75
Leak/Splash	66	66
Fluid/Blood Leak	47	47
Material Twisted/Bent	46	46
Material Deformation	43	43
Deformation Due to Compressive Stress	33	33
No Display/Image	32	32
Detachment of Device or Device Component	30	30
Defective Component	29	29
Material Split, Cut or Torn	28	28
Failure to Clean Adequately	24	24
Device Contamination with Body Fluid	21	21
Stretched	18	18
Mechanical Problem	16	16
Mechanical Jam	15	15
Entrapment of Device	15	15
Material Integrity Problem	15	15
Material Separation	13	13
Data Problem	12	12
Defective Device	12	12
Material Puncture/Hole	12	12
Contamination /Decontamination Problem	11	11
Contamination	11	11
Output Problem	11	11
Improper or Incorrect Procedure or Method	9	9
No Apparent Adverse Event	9	9
Device Contamination with Chemical or Other Material	9	9
Scratched Material	9	9
Device Reprocessing Problem	8	8
Crack	8	8
Therapeutic or Diagnostic Output Failure	7	7
Nonstandard Device	7	7
Display or Visual Feedback Problem	6	6
Patient-Device Incompatibility	6	6
Positioning Problem	6	6
Patient Device Interaction Problem	6	6
Dent in Material	4	4
Failure to Advance	4	4
Image Display Error/Artifact	4	4
Application Program Freezes, Becomes Nonfunctional	4	4
Material Perforation	4	4
Microbial Contamination of Device	4	4
Material Discolored	3	3
Positioning Failure	3	3
Unable to Obtain Readings	3	3
Sharp Edges	3	3
Device Handling Problem	3	3
Gel Leak	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1405	1405
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	15	15
No Patient Involvement	12	12
Bacterial Infection	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
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
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
Itching Sensation	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