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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device transducer, ultrasonic, diagnostic
Product CodeITX
Regulation Number 892.1570
Device Class 2


Premarket Reviews
ManufacturerDecision
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 75 75

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 154 154
Adverse Event Without Identified Device or Use Problem 81 81
Break 66 66
Fluid/Blood Leak 43 43
Leak/Splash 35 35
Defective Component 28 28
No Display/Image 25 25
Detachment of Device or Device Component 19 19
Mechanical Problem 16 16
Failure to Clean Adequately 14 14
Mechanical Jam 13 13
Therapeutic or Diagnostic Output Failure 12 12
Device Contamination with Body Fluid 12 12
Material Separation 11 11
Defective Device 11 11
Entrapment of Device 11 11
Device Contamination with Chemical or Other Material 10 10
Data Problem 10 10
Material Puncture/Hole 10 10
Improper or Incorrect Procedure or Method 9 9
Contamination 8 8
Material Twisted/Bent 8 8
Material Split, Cut or Torn 8 8
Contamination /Decontamination Problem 8 8
Image Display Error/Artifact 8 8
Display or Visual Feedback Problem 8 8
Nonstandard Device 7 7
Output Problem 6 6
Positioning Problem 6 6
No Apparent Adverse Event 6 6
Patient-Device Incompatibility 6 6
Device Reprocessing Problem 6 6
Temperature Problem 5 5
Microbial Contamination of Device 4 4
Material Deformation 4 4
Patient Device Interaction Problem 4 4
Material Integrity Problem 4 4
Application Program Freezes, Becomes Nonfunctional 4 4
Device Displays Incorrect Message 3 3
Signal Artifact/Noise 3 3
Failure to Advance 3 3
Loss of Power 3 3
Gel Leak 3 3
Insufficient Information 3 3
Material Perforation 3 3
Unable to Obtain Readings 3 3
Difficult to Insert 3 3
Computer Software Problem 2 2
Device Markings/Labelling Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Improper Flow or Infusion 2 2
Stretched 2 2
Crack 2 2
Device Handling Problem 2 2
Positioning Failure 2 2
Off-Label Use 2 2
Failure to Power Up 2 2
Physical Resistance/Sticking 2 2
Unexpected Therapeutic Results 2 2
Material Discolored 2 2
Fire 2 2
Appropriate Term/Code Not Available 2 2
Device Dislodged or Dislocated 2 2
Activation Failure 2 2
Electrical /Electronic Property Problem 2 2
Premature Discharge of Battery 1 1
Difficult or Delayed Positioning 1 1
Delivered as Unsterile Product 1 1
Material Frayed 1 1
Activation, Positioning or Separation Problem 1 1
Intermittent Energy Output 1 1
Incorrect Measurement 1 1
Activation Problem 1 1
Loss of or Failure to Bond 1 1
Structural Problem 1 1
Obstruction of Flow 1 1
Use of Device Problem 1 1
Smoking 1 1
Component Missing 1 1
Operating System Becomes Nonfunctional 1 1
Failure to Sense 1 1
Sparking 1 1
Difficult to Remove 1 1
Display Difficult to Read 1 1
Tear, Rip or Hole in Device Packaging 1 1
Product Quality Problem 1 1
Charging Problem 1 1
Energy Output Problem 1 1
Device Contaminated at the User Facility 1 1
Battery Problem 1 1
Problem with Removal of Enzymatic Cleaner 1 1
Electrical Shorting 1 1
Dent in Material 1 1
Unexpected Color 1 1
Unexpected Shutdown 1 1
Environmental Particulates 1 1
Material Too Rigid or Stiff 1 1
Unsealed Device Packaging 1 1
Device Damaged by Another Device 1 1
Collapse 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 347 347
No Consequences Or Impact To Patient 109 109
No Known Impact Or Consequence To Patient 82 82
Insufficient Information 25 25
Pneumothorax 20 20
No Patient Involvement 19 19
Hemorrhage/Bleeding 15 15
Bacterial Infection 11 11
Stenosis 9 9
Foreign Body In Patient 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Unspecified Infection 6 6
Injury 6 6
Perforation of Esophagus 6 6
Burn, Thermal 5 5
Pneumonia 4 4
Chest Pain 4 4
Rash 4 4
Fever 4 4
Perforation of Vessels 4 4
Sepsis 3 3
No Code Available 3 3
Perforation 3 3
Pain 3 3
Laceration(s) of Esophagus 3 3
Patient Problem/Medical Problem 3 3
Hypoxia 2 2
Necrosis 2 2
Obstruction/Occlusion 2 2
Respiratory Failure 2 2
Pancreatitis 2 2
Dyspnea 2 2
Cardiac Arrest 2 2
Itching Sensation 2 2
Device Embedded In Tissue or Plaque 2 2
Air Embolism 2 2
Urinary Retention 2 2
Inflammation 2 2
Vaginal Mucosa Damage 2 2
Burning Sensation 2 2
Fibrosis 2 2
Sore Throat 1 1
Scar Tissue 1 1
Laceration(s) 1 1
Cough 1 1
Unspecified Respiratory Problem 1 1
Abortion 1 1
Vascular Dissection 1 1
Abrasion 1 1
Thrombosis/Thrombus 1 1
Skin Burning Sensation 1 1
Embolism/Embolus 1 1
Chills 1 1
Pleural Empyema 1 1
Localized Skin Lesion 1 1
Hemoptysis 1 1
Tissue Damage 1 1
Skin Irritation 1 1
Dysphagia/ Odynophagia 1 1
Vomiting 1 1
Bronchospasm 1 1
Embolus 1 1
Fistula 1 1
Purulent Discharge 1 1
Decreased Appetite 1 1
Headache 1 1
Nodule 1 1
Low Oxygen Saturation 1 1
Fluid Discharge 1 1
Ulceration 1 1
Conjunctivitis 1 1
Occlusion 1 1
Hematoma 1 1
Taste Disorder 1 1
Bronchial Hemorrhage 1 1
Congenital Defect/Deformity 1 1
Skin Tears 1 1
Swelling/ Edema 1 1
Seroma 1 1
Syncope/Fainting 1 1
Skin Inflammation/ Irritation 1 1
Blurred Vision 1 1
Electric Shock 1 1
No Information 1 1
Gastroesophageal Burn 1 1
Urinary Tract Infection 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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