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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, gastrointestinal motility (electrical)
Product CodeFFX
Regulation Number 876.1725
Device Class 2


Premarket Reviews
ManufacturerDecision
ANX ROBOTICA CORP.
  SUBSTANTIALLY EQUIVALENT 2
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 2
CROSPON LTD
  SUBSTANTIALLY EQUIVALENT 1
DIVERSATEK HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
LABORIE MEDICAL TECHNOLOGIES CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDIFACTIA AB
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 27 27
2020 20 20
2021 26 26
2022 31 31
2023 51 51
2024 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Remove 86 86
Material Integrity Problem 18 18
Material Deformation 12 12
Insufficient Information 10 10
Adverse Event Without Identified Device or Use Problem 10 10
Therapeutic or Diagnostic Output Failure 9 9
Failure of Device to Self-Test 6 6
Failure to Calibrate 5 5
Pressure Problem 4 4
Material Split, Cut or Torn 3 3
Device Displays Incorrect Message 3 3
Detachment of Device or Device Component 3 3
Break 3 3
Gradient Increase 3 3
Poor Quality Image 3 3
Product Quality Problem 3 3
Inadequacy of Device Shape and/or Size 3 3
Smoking 2 2
Device Difficult to Program or Calibrate 2 2
Excess Flow or Over-Infusion 2 2
Material Fragmentation 2 2
Device Sensing Problem 2 2
Defective Component 2 2
Defective Device 2 2
Application Program Problem 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Material Separation 2 2
Premature Separation 2 2
Air/Gas in Device 1 1
Physical Resistance/Sticking 1 1
Unintended Electrical Shock 1 1
Data Problem 1 1
Patient Device Interaction Problem 1 1
Protective Measures Problem 1 1
No Apparent Adverse Event 1 1
Failure to Advance 1 1
Date/Time-Related Software Problem 1 1
Calibration Problem 1 1
Computer Operating System Problem 1 1
Activation, Positioning or Separation Problem 1 1
Impedance Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Output Problem 1 1
Device Alarm System 1 1
Intermittent Continuity 1 1
Deflation Problem 1 1
Display or Visual Feedback Problem 1 1
Fluid/Blood Leak 1 1
Failure to Power Up 1 1
Device Difficult to Setup or Prepare 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 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 67 67
Insufficient Information 23 23
Hemorrhage/Bleeding 15 15
Foreign Body In Patient 12 12
No Consequences Or Impact To Patient 11 11
Pain 8 8
No Known Impact Or Consequence To Patient 6 6
Blood Loss 6 6
Unspecified Tissue Injury 6 6
Epistaxis 5 5
Discomfort 5 5
Injury 5 5
Airway Obstruction 5 5
Sedation 4 4
Sore Throat 4 4
Tissue Damage 4 4
No Code Available 4 4
Obstruction/Occlusion 4 4
Nasal Obstruction 4 4
No Patient Involvement 3 3
No Information 3 3
Convulsion/Seizure 2 2
Radiation Exposure, Unintended 2 2
Perforation of Esophagus 2 2
Inflammation 2 2
Laceration(s) 2 2
Failure of Implant 1 1
Unspecified Infection 1 1
Bradycardia 1 1
Dyspnea 1 1
Hematoma 1 1
Pneumothorax 1 1
Scar Tissue 1 1
Laceration(s) of Esophagus 1 1
Device Embedded In Tissue or Plaque 1 1
Patient Problem/Medical Problem 1 1
Electric Shock 1 1
Cough 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Diversatek Healthcare III Sep-07-2023
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