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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
Regulation Description Diagnostic ultrasonic transducer.
Product CodeITX
Regulation Number 892.1570
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOBOT SURGICAL PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  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
GEOTEK MEDIKAL LTD STI
  SUBSTANTIALLY EQUIVALENT 1
HUNTLEIGH HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
KOELIS
  SUBSTANTIALLY EQUIVALENT 2
MEDXPRESS.PRO
  SUBSTANTIALLY EQUIVALENT 1
STROKE2PREVENT B.V.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 412 412
2018 129 129
2019 119 119
2020 116 116
2021 146 146

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 221 221
Poor Quality Image 128 128
Adverse Event Without Identified Device or Use Problem 55 55
Break 45 45
Fluid Leak 34 34
No Display/Image 23 23
Defective Component 23 23
Signal Artifact/Noise 22 22
Detachment Of Device Component 22 22
Device Operates Differently Than Expected 20 20
Detachment of Device or Device Component 18 18
Temperature Problem 17 17
Image Display Error/Artifact 15 15
Positioning Problem 14 14
Device Contamination with Chemical or Other Material 14 14
Mechanical Jam 13 13
Output Problem 13 13
Leak/Splash 12 12
Mechanical Problem 12 12
Entrapment of Device 11 11
Therapeutic or Diagnostic Output Failure 11 11
Device Operational Issue 11 11
Defective Device 10 10
Contamination /Decontamination Problem 10 10
Loss of Power 10 10
Display or Visual Feedback Problem 9 9
Improper or Incorrect Procedure or Method 9 9
Data Problem 9 9
Crack 8 8
Material Puncture/Hole 8 8
Overheating of Device 8 8
Material Separation 8 8
Microbial Contamination of Device 7 7
Nonstandard Device 7 7
Insufficient Information 7 7
Noise, Audible 7 7
Device Inoperable 6 6
Patient-Device Incompatibility 6 6
Battery Problem 6 6
Difficult to Remove 6 6
Retraction Problem 5 5
Loss of or Failure to Bond 5 5
Material Twisted/Bent 5 5
Improper Device Output 4 4
Device Damaged by Another Device 4 4
Patient Device Interaction Problem 4 4
Appropriate Term/Code Not Available 4 4
No Apparent Adverse Event 4 4
Hole In Material 4 4
Fracture 3 3
Component Falling 3 3
Computer Software Problem 3 3
Contamination 3 3
Failure to Power Up 3 3
Component Missing 3 3
Device Contamination with Body Fluid 3 3
Residue After Decontamination 3 3
Difficult to Insert 3 3
Failure to Sense 3 3
Operating System Becomes Nonfunctional 3 3
Application Program Freezes, Becomes Nonfunctional 3 3
Device Dislodged or Dislocated 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Material Deformation 3 3
Communication or Transmission Problem 3 3
Use of Device Problem 2 2
Failure to Advance 2 2
Failure to Disconnect 2 2
Difficult or Delayed Activation 2 2
Improper Flow or Infusion 2 2
Loss of Data 2 2
Physical Resistance/Sticking 2 2
Mechanics Altered 2 2
Torn Material 2 2
Smoking 2 2
Device Stops Intermittently 2 2
Stretched 2 2
Delivered as Unsterile Product 2 2
No Device Output 2 2
Unsealed Device Packaging 2 2
Melted 2 2
Application Interface Becomes Non-Functional Or Program Exits Abnormally 2 2
Thermal Decomposition of Device 2 2
Gel Leak 2 2
Erratic or Intermittent Display 2 2
Loose or Intermittent Connection 2 2
Electrical /Electronic Property Problem 2 2
Fire 2 2
Positioning Failure 2 2
Material Discolored 1 1
Disconnection 1 1
Failure to Disinfect 1 1
Display Difficult to Read 1 1
Image Resolution Poor 1 1
Device Reprocessing Problem 1 1
Complete Blockage 1 1
Coiled 1 1
Collapse 1 1
Failure To Adhere Or Bond 1 1
Premature Discharge of Battery 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 337 337
No Known Impact Or Consequence To Patient 198 198
No Clinical Signs, Symptoms or Conditions 113 113
No Patient Involvement 73 73
No Information 47 47
Insufficient Information 35 35
No Code Available 26 26
Bacterial Infection 16 16
Perforation of Esophagus 11 11
Stenosis 9 9
Pneumothorax 8 8
Unspecified Infection 7 7
Injury 7 7
Foreign Body In Patient 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Burn, Thermal 5 5
Perforation of Vessels 4 4
Device Embedded In Tissue or Plaque 4 4
Patient Problem/Medical Problem 4 4
Chest Pain 4 4
Death 4 4
Rash 4 4
Laceration(s) of Esophagus 4 4
Pain 3 3
Perforation 3 3
Burn(s) 3 3
Burning Sensation 3 3
Shock 2 2
Inflammation 2 2
Itching Sensation 2 2
Laceration(s) 2 2
Dysphagia/ Odynophagia 2 2
Fever 2 2
Hematoma 2 2
Hemorrhage/Bleeding 2 2
Sepsis 2 2
Tissue Damage 2 2
Ulceration 1 1
Urinary Retention 1 1
Urinary Tract Infection 1 1
Ventricular Tachycardia 1 1
Seroma 1 1
Pleural Effusion 1 1
Pneumonia 1 1
Renal Failure 1 1
Scar Tissue 1 1
Fistula 1 1
Dyspnea 1 1
Embolus 1 1
Necrosis 1 1
Occlusion 1 1
Cardiac Arrest 1 2
Abortion 1 1
Abrasion 1 1
Arrhythmia 1 2
Purulent Discharge 1 1
Congenital Defect/Deformity 1 1
Conjunctivitis 1 1
Skin Irritation 1 1
Blurred Vision 1 1
Chills 1 1
Rupture 1 1
Electric Shock 1 1
Sedation 1 1
Obstruction/Occlusion 1 1
Skin Inflammation 1 1
Needle Stick/Puncture 1 1
Skin Tears 1 1
Vascular Dissection 1 1
Not Applicable 1 1
Taste Disorder 1 1
Embolism/Embolus 1 1
Bronchial Hemorrhage 1 1
Cough 1 1
Localized Skin Lesion 1 1
Skin Inflammation/ Irritation 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 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 Hitachi Medical Systems America Inc II Feb-20-2020
11 Hitachi Medical Systems America Inc II Mar-01-2018
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 Nov-27-2020
17 Philips Ultrasound Inc II May-01-2020
18 Red Medical Supplies I Oct-14-2021
19 Scrip Inc I Nov-17-2021
20 Verathon, Inc. II Dec-03-2020
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