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TPLC
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2024
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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
1
HUNTLEIGH HEALTHCARE LIMITED
SUBSTANTIALLY EQUIVALENT
1
MEDXPRESS.PRO
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
119
119
2020
116
116
2021
146
146
2022
87
87
2023
145
145
2024
169
169
Device Problems
MDRs with this Device Problem
Events in those MDRs
Poor Quality Image
238
238
Adverse Event Without Identified Device or Use Problem
85
85
Break
66
66
Fluid/Blood Leak
44
44
Leak/Splash
35
35
Defective Component
28
28
No Display/Image
27
27
Detachment of Device or Device Component
19
19
Mechanical Problem
16
16
Failure to Clean Adequately
15
15
Mechanical Jam
13
13
Entrapment of Device
13
13
Device Contamination with Body Fluid
12
12
Therapeutic or Diagnostic Output Failure
12
12
Material Separation
11
11
Defective Device
11
11
Device Contamination with Chemical or Other Material
10
10
Material Puncture/Hole
10
10
Data Problem
10
10
Improper or Incorrect Procedure or Method
9
9
Contamination /Decontamination Problem
8
8
Image Display Error/Artifact
8
8
Display or Visual Feedback Problem
8
8
Contamination
8
8
Material Twisted/Bent
8
8
Material Split, Cut or Torn
8
8
Nonstandard Device
7
7
Device Reprocessing Problem
6
6
Patient-Device Incompatibility
6
6
Output Problem
6
6
Positioning Problem
6
6
No Apparent Adverse Event
6
6
Material Integrity Problem
5
5
Temperature Problem
5
5
Application Program Freezes, Becomes Nonfunctional
4
4
Patient Device Interaction Problem
4
4
Material Deformation
4
4
Microbial Contamination of Device
4
4
Material Perforation
3
3
Unable to Obtain Readings
3
3
Failure to Advance
3
3
Device Displays Incorrect Message
3
3
Signal Artifact/Noise
3
3
Loss of Power
3
3
Difficult to Insert
3
3
Gel Leak
3
3
Insufficient Information
3
3
Appropriate Term/Code Not Available
2
2
Device Handling Problem
2
2
Activation Failure
2
2
Physical Resistance/Sticking
2
2
Computer Software Problem
2
2
Failure to Power Up
2
2
Off-Label Use
2
2
Crack
2
2
Electrical /Electronic Property Problem
2
2
Problem with Removal of Enzymatic Cleaner
2
2
Fire
2
2
Positioning Failure
2
2
Material Discolored
2
2
Device Markings/Labelling Problem
2
2
Improper Flow or Infusion
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Device Dislodged or Dislocated
2
2
Stretched
2
2
Unexpected Therapeutic Results
2
2
Use of Device Problem
1
1
Smoking
1
1
Difficult to Remove
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Material Too Rigid or Stiff
1
1
Material Rupture
1
1
Failure to Sense
1
1
Device Damaged Prior to Use
1
1
Component Missing
1
1
Tear, Rip or Hole in Device Packaging
1
1
Obstruction of Flow
1
1
Structural Problem
1
1
Failure to Align
1
1
Electrical Shorting
1
1
Environmental Particulates
1
1
Device Damaged by Another Device
1
1
Activation, Positioning or Separation Problem
1
1
Sparking
1
1
Malposition of Device
1
1
Dent in Material
1
1
Battery Problem
1
1
Charging Problem
1
1
Display Difficult to Read
1
1
Erratic or Intermittent Display
1
1
Difficult or Delayed Positioning
1
1
Collapse
1
1
Premature Discharge of Battery
1
1
Loss of or Failure to Bond
1
1
Thermal Decomposition of Device
1
1
Product Quality Problem
1
1
Delivered as Unsterile Product
1
1
Energy Output Problem
1
1
No Device Output
1
1
Overheating of Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
436
436
No Consequences Or Impact To Patient
109
109
No Known Impact Or Consequence To Patient
82
82
Insufficient Information
25
25
Pneumothorax
21
21
No Patient Involvement
19
19
Hemorrhage/Bleeding
16
16
Bacterial Infection
11
11
Foreign Body In Patient
10
10
Stenosis
9
9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
7
7
Injury
6
6
Perforation of Esophagus
6
6
Unspecified Infection
6
6
Burn, Thermal
5
5
Perforation of Vessels
4
4
Rash
4
4
Pneumonia
4
4
Chest Pain
4
4
Fever
4
4
Sepsis
3
3
Pain
3
3
Perforation
3
3
Patient Problem/Medical Problem
3
3
No Code Available
3
3
Laceration(s) of Esophagus
3
3
Pancreatitis
3
3
Gastroesophageal Burn
2
2
Device Embedded In Tissue or Plaque
2
2
Fibrosis
2
2
Urinary Retention
2
2
Urinary Tract Infection
2
2
Vaginal Mucosa Damage
2
2
Respiratory Failure
2
2
Obstruction/Occlusion
2
2
Burning Sensation
2
2
Necrosis
2
2
Inflammation
2
2
Itching Sensation
2
2
Air Embolism
2
2
Hypoxia
2
2
Dyspnea
2
2
Cardiac Arrest
2
2
Abortion
1
1
Abrasion
1
1
Congenital Defect/Deformity
1
1
Conjunctivitis
1
1
Purulent Discharge
1
1
Dysphagia/ Odynophagia
1
1
Embolus
1
1
Fistula
1
1
Headache
1
1
Hematoma
1
1
Hemoptysis
1
1
Scar Tissue
1
1
Seroma
1
1
Skin Irritation
1
1
Tissue Damage
1
1
Ulceration
1
1
Laceration(s)
1
1
Occlusion
1
1
Chills
1
1
Low Oxygen Saturation
1
1
Skin Tears
1
1
Electric Shock
1
1
Bronchospasm
1
1
Blurred Vision
1
1
Vomiting
1
1
Sore Throat
1
1
No Information
1
1
Vascular Dissection
1
1
Fluid Discharge
1
1
Syncope/Fainting
1
1
Taste Disorder
1
1
Embolism/Embolus
1
1
Thrombosis/Thrombus
1
1
Bronchial Hemorrhage
1
1
Cough
1
1
Pleural Empyema
1
1
Unspecified Respiratory Problem
1
1
Skin Burning Sensation
1
1
Localized Skin Lesion
1
1
Skin Inflammation/ Irritation
1
1
Nodule
1
1
Decreased Appetite
1
1
Swelling/ Edema
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
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