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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
CORBIN CLINICAL RESOURCES, LLC
  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
HITACHI ALOKA MEDICAL AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
HUNTLEIGH HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
KOELIS
  SUBSTANTIALLY EQUIVALENT 2
MEDXPRESS.PRO
  SUBSTANTIALLY EQUIVALENT 1
SHEATHING TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
STROKE2PREVENT B.V.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 285 285
2017 373 373
2018 127 127
2019 119 119
2020 117 117
2021 109 109

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 246 246
Poor Quality Image 143 143
Device Operates Differently Than Expected 78 78
Adverse Event Without Identified Device or Use Problem 58 58
Break 48 48
Fluid Leak 30 30
Mechanical Problem 26 26
Detachment Of Device Component 25 25
No Display/Image 24 24
Use of Device Problem 24 24
Defective Component 23 23
Mechanics Altered 22 22
Mechanical Jam 21 21
Signal Artifact/Noise 20 20
Incorrect, Inadequate or Imprecise Resultor Readings 18 18
Detachment of Device or Device Component 18 18
Positioning Problem 17 17
Image Display Error/Artifact 15 15
Temperature Problem 15 15
Insufficient Information 15 15
Device Operational Issue 14 14
Computer Operating System Problem 14 14
Entrapment of Device 14 14
Device Inoperable 12 12
Device Contamination with Chemical or Other Material 10 10
Defective Device 10 10
Therapeutic or Diagnostic Output Failure 10 10
Material Separation 10 10
Loss of Power 10 10
Overheating of Device 10 10
Crack 10 10
Output Problem 9 9
Data Problem 9 9
Leak/Splash 9 9
Contamination /Decontamination Problem 8 8
Noise, Audible 8 8
Hole In Material 8 8
Material Puncture/Hole 7 7
Difficult to Remove 7 7
Display or Visual Feedback Problem 7 7
Improper Device Output 6 6
Battery Problem 6 6
Application Interface Becomes Non-Functional Or Program Exits Abnormally 5 5
Fracture 5 5
Loss of or Failure to Bond 5 5
Failure to Power Up 5 5
Retraction Problem 5 5
Nonstandard Device 5 5
Microbial Contamination of Device 5 5
Device Damaged by Another Device 4 4
Device Dislodged or Dislocated 4 4
Material Twisted/Bent 4 4
No Apparent Adverse Event 4 4
Smoking 4 4
Appropriate Term/Code Not Available 4 4
Contamination 4 4
Improper or Incorrect Procedure or Method 4 4
Device Contamination with Body Fluid 4 4
Connection Problem 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Material Deformation 3 3
Sticking 3 3
Residue After Decontamination 3 3
Difficult to Insert 3 3
Component Falling 3 3
Computer Software Problem 3 3
Patient Device Interaction Problem 3 3
Physical Property Issue 3 3
Operating System Becomes Nonfunctional 3 3
Communication or Transmission Problem 3 3
Component Missing 3 3
Patient-Device Incompatibility 2 2
Improper Flow or Infusion 2 2
Torn Material 2 2
Failure to Sense 2 2
No Device Output 2 2
Unsealed Device Packaging 2 2
Melted 2 2
Gel Leak 2 2
Fire 2 2
Positioning Failure 2 2
Thermal Decomposition of Device 2 2
Erratic or Intermittent Display 2 2
Electrical /Electronic Property Problem 2 2
Loose or Intermittent Connection 2 2
Delivered as Unsterile Product 2 2
Product Quality Problem 2 2
Device Stops Intermittently 2 2
Low Readings 2 2
Failure to Advance 2 2
Failure to Disconnect 2 2
Difficult or Delayed Activation 2 2
Device Disinfection Or Sterilization Issue 2 2
Physical Resistance/Sticking 2 2
Application Program Freezes, Becomes Nonfunctional 2 2
Failure to Clean Adequately 1 1
Device Contaminated at the User Facility 1 1
Audible Prompt/Feedback Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Electrical Shorting 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 461 461
No Known Impact Or Consequence To Patient 313 313
No Patient Involvement 78 78
No Clinical Signs, Symptoms or Conditions 71 71
No Information 66 66
No Code Available 30 30
Bacterial Infection 13 13
Perforation of Esophagus 11 11
Injury 10 10
Stenosis 9 9
Insufficient Information 9 9
Pneumothorax 8 8
Death 8 8
Low Blood Pressure/ Hypotension 6 6
Perforation 6 6
Unspecified Infection 5 5
Burn, Thermal 5 5
Device Embedded In Tissue or Plaque 5 5
Patient Problem/Medical Problem 4 4
Hemorrhage/Bleeding 4 4
Laceration(s) of Esophagus 4 4
Chest Pain 4 4
Burn(s) 4 4
Perforation of Vessels 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Foreign Body In Patient 3 3
Cardiac Perforation 2 2
Burning Sensation 2 2
Laceration(s) 2 2
Shock 2 2
Tissue Damage 2 2
Pericardial Effusion 2 2
Dysphagia/ Odynophagia 2 2
Inflammation 2 2
Hematoma 2 2
Rash 2 2
Renal Failure 1 1
Sepsis 1 1
Skin Irritation 1 1
Torsades-de-Pointes 1 1
Ulceration 1 1
Ventricular Tachycardia 1 1
Abrasion 1 1
Occlusion 1 1
Dyspnea 1 1
Fever 1 1
Cardiopulmonary Arrest 1 1
Conjunctivitis 1 1
Taste Disorder 1 1
Bronchial Hemorrhage 1 1
Cough 1 1
Chills 1 1
Skin Inflammation 1 1
Rupture 1 1
Cardiac Tamponade 1 1
Sedation 1 1
Urinary Retention 1 1
Urinary Tract Infection 1 1
Ventricular Fibrillation 1 1
Blurred Vision 1 1
Necrosis 1 1
Pain 1 1
Pleural Effusion 1 1
Pneumonia 1 1
Arrhythmia 1 2
Bradycardia 1 1
Cardiac Arrest 1 2
Itching Sensation 1 1
Purulent Discharge 1 1
Embolus 1 1
Heart Failure 1 1
Scar Tissue 1 1
Seroma 1 1
Needle Stick/Puncture 1 1
Not Applicable 1 1
Electric Shock 1 1
Blood Loss 1 1
Localized Skin Lesion 1 1
Swelling/ Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Athena Medical Products Inc I Sep-09-2021
2 CIVCO Medical Instruments Co., Inc. II Dec-07-2018
3 Civco Medical Instruments Co. Inc. II Aug-29-2018
4 Civco Medical Instruments Co. Inc. II Aug-22-2018
5 Exact Medical Manufacturing, Inc. II Jun-21-2021
6 Hitachi Medical Systems America Inc II Feb-20-2020
7 Hitachi Medical Systems America Inc II Mar-01-2018
8 Mac Medical Supply Co Inc I Sep-17-2021
9 Olympus Corporation of the Americas II Nov-27-2020
10 Pentax Medical Company II Jun-28-2016
11 Philips Ultrasound Inc II May-01-2020
12 Verathon, Inc. II Dec-03-2020
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