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	636	636
Break	109	109
Adverse Event Without Identified Device or Use Problem	97	97
Leak/Splash	55	55
Fluid/Blood Leak	48	48
Material Twisted/Bent	37	37
Material Deformation	36	36
No Display/Image	34	34
Defective Component	33	33
Deformation Due to Compressive Stress	32	32
Detachment of Device or Device Component	26	26
Material Split, Cut or Torn	25	25
Device Contamination with Body Fluid	20	20
Failure to Clean Adequately	20	20
Mechanical Problem	18	18
Stretched	17	17
Mechanical Jam	15	15
Entrapment of Device	14	14
Material Separation	13	13
Data Problem	12	12
Therapeutic or Diagnostic Output Failure	12	12
Material Puncture/Hole	12	12
Contamination /Decontamination Problem	11	11
Output Problem	11	11
Material Integrity Problem	11	11
Defective Device	11	11
Display or Visual Feedback Problem	10	10
Contamination	10	10
Device Contamination with Chemical or Other Material	10	10
No Apparent Adverse Event	9	9
Improper or Incorrect Procedure or Method	9	9
Image Display Error/Artifact	8	8
Scratched Material	8	8
Device Reprocessing Problem	7	7
Nonstandard Device	7	7
Positioning Problem	7	7
Patient-Device Incompatibility	6	6
Crack	6	6
Patient Device Interaction Problem	6	6
Temperature Problem	5	5
Failure to Advance	4	4
Application Program Freezes, Becomes Nonfunctional	4	4
Microbial Contamination of Device	4	4
Insufficient Information	3	3
Gel Leak	3	3
Overheating of Device	3	3
Physical Resistance/Sticking	3	3
Electrical /Electronic Property Problem	3	3
Difficult to Insert	3	3
Unable to Obtain Readings	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1063	1063
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
Unspecified Infection	6	6
Injury	6	6
Burn, Thermal	5	5
Perforation of Vessels	4	4
Pneumonia	4	4
Chest Pain	4	4
Rash	4	4
Fever	4	4
Laceration(s) of Esophagus	4	4
Perforation	3	3
Patient Problem/Medical Problem	3	3
No Code Available	3	3
Sepsis	3	3
Pain	3	3
Pancreatitis	3	3
Hemoptysis	2	2
Inflammation	2	2
Respiratory Failure	2	2
Air Embolism	2	2
Fibrosis	2	2
Fluid Discharge	2	2
Itching Sensation	2	2
Obstruction/Occlusion	2	2
Urinary Tract Infection	2	2
Device Embedded In Tissue or Plaque	2	2
Necrosis	2	2
Cardiac Arrest	2	2
Vaginal Mucosa Damage	2	2
Gastroesophageal Burn	2	2
Burning Sensation	2	2
Dyspnea	2	2
Urinary Retention	2	2
Electric Shock	2	2
Hypoxia	2	2
Decreased Appetite	1	1
Dysphagia/ Odynophagia	1	1
Ulceration	1	1
Bronchospasm	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