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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device transducer, ultrasonic, diagnostic
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
GLOBAL PROTECTION CORP.
  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
2022 57 57

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 221 221
Poor Quality Image 129 129
Adverse Event Without Identified Device or Use Problem 65 65
Break 51 51
Fluid Leak 44 44
No Display/Image 26 26
Defective Component 23 23
Signal Artifact/Noise 22 22
Detachment Of Device Component 22 22
Detachment of Device or Device Component 22 22
Device Operates Differently Than Expected 20 20
Leak/Splash 18 18
Temperature Problem 17 17
Output Problem 15 15
Device Contamination with Chemical or Other Material 15 15
Image Display Error/Artifact 15 15
Positioning Problem 14 14
Mechanical Jam 13 13
Mechanical Problem 13 13
Entrapment of Device 11 11
Therapeutic or Diagnostic Output Failure 11 11
Device Operational Issue 11 11
Contamination /Decontamination Problem 11 11
Defective Device 10 10
Display or Visual Feedback Problem 10 10
Loss of Power 10 10
Material Separation 9 9
Crack 9 9
Improper or Incorrect Procedure or Method 9 9
Data Problem 9 9
Insufficient Information 8 8
Overheating of Device 8 8
Material Puncture/Hole 8 8
Nonstandard Device 7 7
Microbial Contamination of Device 7 7
Noise, Audible 7 7
No Apparent Adverse Event 6 6
Device Inoperable 6 6
Patient-Device Incompatibility 6 6
Battery Problem 6 6
Difficult to Remove 6 6
Contamination 6 6
Loss of or Failure to Bond 5 5
Retraction Problem 5 5
Material Twisted/Bent 5 5
Appropriate Term/Code Not Available 4 4
Patient Device Interaction Problem 4 4
Application Program Freezes, Becomes Nonfunctional 4 4
Device Damaged by Another Device 4 4
Improper Device Output 4 4
Component Missing 4 4
Device Contamination with Body Fluid 4 4
Failure to Power Up 4 4
Hole In Material 4 4
Fracture 3 3
Gel Leak 3 3
Component Falling 3 3
Computer Software Problem 3 3
Difficult to Insert 3 3
Residue After Decontamination 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Material Deformation 3 3
Device Dislodged or Dislocated 3 3
Failure to Sense 3 3
Communication or Transmission Problem 3 3
Failure to Clean Adequately 3 3
Operating System Becomes Nonfunctional 3 3
Mechanics Altered 2 2
Torn Material 2 2
Material Split, Cut or Torn 2 2
Physical Resistance/Sticking 2 2
Use of Device Problem 2 2
Material Perforation 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
Smoking 2 2
Device Stops Intermittently 2 2
Stretched 2 2
Unexpected Therapeutic Results 2 2
No Device Output 2 2
Melted 2 2
Delivered as Unsterile Product 2 2
Unsealed Device Packaging 2 2
Application Interface Becomes Non-Functional Or Program Exits Abnormally 2 2
Thermal Decomposition of Device 2 2
Device Reprocessing Problem 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 2 2
Disconnection 1 1
Failure to Disinfect 1 1
Display Difficult to Read 1 1
Incorrect Measurement 1 1
Image Resolution Poor 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 154 154
No Patient Involvement 73 73
No Information 47 47
Insufficient Information 38 38
No Code Available 26 26
Bacterial Infection 17 17
Perforation of Esophagus 11 11
Pneumothorax 10 10
Stenosis 9 9
Injury 7 7
Foreign Body In Patient 7 7
Hemorrhage/Bleeding 7 7
Unspecified Infection 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Burn, Thermal 5 5
Patient Problem/Medical Problem 4 4
Device Embedded In Tissue or Plaque 4 4
Laceration(s) of Esophagus 4 4
Perforation of Vessels 4 4
Chest Pain 4 4
Death 4 4
Rash 4 4
Perforation 4 4
Pain 3 3
Burn(s) 3 3
Burning Sensation 3 3
Vaginal Mucosa Damage 2 2
Pneumonia 2 2
Pancreatitis 2 2
Inflammation 2 2
Itching Sensation 2 2
Laceration(s) 2 2
Necrosis 2 2
Dysphagia/ Odynophagia 2 2
Fever 2 2
Hematoma 2 2
Sepsis 2 2
Shock 2 2
Tissue Damage 2 2
Ulceration 1 1
Urinary Retention 1 1
Urinary Tract Infection 1 1
Skin Irritation 1 1
Seroma 1 1
Pleural Effusion 1 1
Renal Failure 1 1
Scar Tissue 1 1
Fistula 1 1
Dyspnea 1 1
Embolus 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
Localized Skin Lesion 1 1
Skin Inflammation/ Irritation 1 1
Swelling/ Edema 1 1
Taste Disorder 1 1
Embolism/Embolus 1 1
Thrombosis/Thrombus 1 1
Bronchial Hemorrhage 1 1
Cough 1 1
Not Applicable 1 1
Vascular Dissection 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
Ventricular Tachycardia 1 1
Blurred Vision 1 1
Chills 1 1
Rupture 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 Huntleigh Healthcare Ltd. II Apr-20-2022
13 Lumenis, Inc. I Nov-04-2021
14 Mac Medical Supply Co Inc I Sep-17-2021
15 National Distribution & Contracting Inc I Oct-13-2021
16 North Coast Medical Inc I Sep-29-2021
17 Olympus Corporation of the Americas II May-05-2022
18 Olympus Corporation of the Americas II Nov-27-2020
19 Philips Ultrasound Inc II May-01-2020
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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