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TPLC
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Device
transducer, ultrasonic, diagnostic
Product Code
ITX
Regulation Number
892.1570
Device Class
2
Premarket Reviews
Manufacturer
Decision
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
CIVCO MEDICAL INSTRUMENTS CO., INC.
SUBSTANTIALLY EQUIVALENT
2
CIVCO MEDICAL SOLUTIONS
SUBSTANTIALLY EQUIVALENT
1
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
EXACT MEDICAL MANUFACTURING
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
KOELIS
SUBSTANTIALLY EQUIVALENT
1
MEDXPRESS.PRO
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
129
129
2019
119
119
2020
116
116
2021
146
146
2022
88
88
2023
21
21
Device Problems
MDRs with this Device Problem
Events in those MDRs
Poor Quality Image
109
109
Adverse Event Without Identified Device or Use Problem
68
68
Break
46
46
Fluid/Blood Leak
34
34
No Display/Image
25
25
Defective Component
21
21
Detachment of Device or Device Component
19
19
Leak/Splash
16
16
Mechanical Problem
15
15
Image Display Error/Artifact
14
14
Mechanical Jam
13
13
Positioning Problem
11
11
Defective Device
11
11
Therapeutic or Diagnostic Output Failure
11
11
Display or Visual Feedback Problem
11
11
Material Puncture/Hole
10
10
Material Separation
10
10
Improper or Incorrect Procedure or Method
10
10
Data Problem
10
10
Device Contamination with Chemical or Other Material
10
10
Device Operates Differently Than Expected
9
9
Device Contamination with Body Fluid
9
9
Signal Artifact/Noise
8
8
Contamination /Decontamination Problem
8
8
Contamination
7
7
Loss of Power
7
7
Nonstandard Device
7
7
Entrapment of Device
6
6
Patient-Device Incompatibility
6
6
Battery Problem
6
6
Output Problem
6
6
Material Split, Cut or Torn
6
6
Noise, Audible
5
5
No Apparent Adverse Event
5
5
Temperature Problem
5
5
Material Twisted/Bent
5
5
Microbial Contamination of Device
5
5
Device Displays Incorrect Message
4
4
Insufficient Information
4
4
Appropriate Term/Code Not Available
4
4
Patient Device Interaction Problem
4
4
Failure to Clean Adequately
4
4
Detachment Of Device Component
4
4
Crack
3
3
Gel Leak
3
3
Hole In Material
3
3
Failure to Power Up
3
3
Difficult to Insert
3
3
Retraction Problem
3
3
Application Program Freezes, Becomes Nonfunctional
3
3
Operating System Becomes Nonfunctional
3
3
Material Deformation
3
3
Material Integrity Problem
2
2
Improper Flow or Infusion
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Device Dislodged or Dislocated
2
2
Mechanics Altered
2
2
Component Missing
2
2
Failure to Advance
2
2
Device Markings/Labelling Problem
2
2
Communication or Transmission Problem
2
2
Physical Resistance/Sticking
2
2
Activation Failure
2
2
Smoking
2
2
Material Perforation
2
2
Stretched
2
2
Unexpected Therapeutic Results
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Delivered as Unsterile Product
2
2
No Device Output
2
2
Melted
2
2
Fire
2
2
Loss of or Failure to Bond
2
2
Erratic or Intermittent Display
2
2
Application Interface Becomes Non-Functional Or Program Exits Abnormally
2
2
Positioning Failure
2
2
Material Discolored
2
2
Computer Software Problem
2
2
Thermal Decomposition of Device
2
2
Device Reprocessing Problem
2
2
Collapse
1
1
Premature Discharge of Battery
1
1
Bent
1
1
Display Difficult to Read
1
1
Intermittent Continuity
1
1
Degraded
1
1
Difficult or Delayed Positioning
1
1
Electrical /Electronic Property Problem
1
1
Fracture
1
1
Incorrect Measurement
1
1
Image Resolution Poor
1
1
Overheating of Device
1
1
Unsealed Device Packaging
1
1
Power Conditioning Problem
1
1
Energy Output Problem
1
1
Off-Label Use
1
1
Product Quality Problem
1
1
Unable to Obtain Readings
1
1
Difficult to Remove
1
1
Device Damaged Prior to Use
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
173
173
No Known Impact Or Consequence To Patient
148
148
No Consequences Or Impact To Patient
147
147
Insufficient Information
21
21
No Patient Involvement
20
20
Pneumothorax
14
14
Bacterial Infection
11
11
Hemorrhage/Bleeding
11
11
Perforation of Esophagus
11
11
No Code Available
11
11
Stenosis
9
9
Foreign Body In Patient
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
Injury
6
6
Unspecified Infection
6
6
Burn, Thermal
5
5
Laceration(s) of Esophagus
4
4
Perforation of Vessels
4
4
No Information
4
4
Patient Problem/Medical Problem
4
4
Rash
4
4
Chest Pain
4
4
Fever
3
3
Pain
3
3
Perforation
3
3
Pneumonia
2
2
Necrosis
2
2
Inflammation
2
2
Itching Sensation
2
2
Vaginal Mucosa Damage
2
2
Sepsis
2
2
Cardiac Arrest
2
2
Device Embedded In Tissue or Plaque
2
2
Pancreatitis
2
2
Burning Sensation
2
2
Hematoma
2
2
Fluid Discharge
1
1
Obstruction/Occlusion
1
1
Needle Stick/Puncture
1
1
Skin Tears
1
1
Chills
1
1
Blurred Vision
1
1
Localized Skin Lesion
1
1
Skin Inflammation/ Irritation
1
1
Swelling/ Edema
1
1
Vascular Dissection
1
1
Taste Disorder
1
1
Embolism/Embolus
1
1
Thrombosis/Thrombus
1
1
Bronchial Hemorrhage
1
1
Cough
1
1
Unspecified Respiratory Problem
1
1
Abortion
1
1
Abrasion
1
1
Fistula
1
1
Hypoxia
1
1
Congenital Defect/Deformity
1
1
Conjunctivitis
1
1
Death
1
1
Purulent Discharge
1
1
Dysphagia/ Odynophagia
1
1
Dyspnea
1
1
Embolus
1
1
Seroma
1
1
Skin Irritation
1
1
Tissue Damage
1
1
Ulceration
1
1
Urinary Retention
1
1
Urinary Tract Infection
1
1
Ventricular Tachycardia
1
1
Scar Tissue
1
1
Laceration(s)
1
1
Occlusion
1
1
Internal Organ Perforation
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
Aesthetics Systems Usa Inc
I
Oct-06-2021
4
Athena Medical Products Inc
I
Sep-09-2021
5
CIVCO Medical Instruments Co., Inc.
II
Dec-07-2018
6
Civco Medical Instruments Co. Inc.
II
Aug-29-2018
7
Civco Medical Instruments Co. Inc.
II
Aug-22-2018
8
DJO, LLC
I
Oct-05-2021
9
Exact Medical Manufacturing, Inc.
II
Jun-21-2021
10
GE Medical Systems, LLC
II
Dec-22-2022
11
Hitachi Medical Systems America Inc
II
Feb-20-2020
12
Hitachi Medical Systems America Inc
II
Mar-01-2018
13
Huntleigh Healthcare Ltd.
II
Apr-20-2022
14
Lumenis, Inc.
I
Nov-04-2021
15
Mac Medical Supply Co Inc
I
Sep-17-2021
16
National Distribution & Contracting Inc
I
Oct-13-2021
17
North Coast Medical Inc
I
Sep-29-2021
18
Olympus Corporation of the Americas
II
May-05-2022
19
Olympus Corporation of the Americas
II
Nov-27-2020
20
Philips Ultrasound Inc
II
May-01-2020
21
Red Medical Supplies
I
Oct-14-2021
22
Scrip Inc
I
Nov-17-2021
23
Verathon, Inc.
II
Dec-03-2020
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