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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
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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