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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
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 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Remove 83 83
Material Integrity Problem 18 18
Material Deformation 10 10
Adverse Event Without Identified Device or Use Problem 9 9
Therapeutic or Diagnostic Output Failure 9 9
Insufficient Information 8 8
Failure of Device to Self-Test 6 6
Pressure Problem 4 4
Failure to Calibrate 4 4
Material Split, Cut or Torn 3 3
Gradient Increase 3 3
Device Displays Incorrect Message 3 3
Product Quality Problem 3 3
Inadequacy of Device Shape and/or Size 3 3
Break 3 3
Detachment of Device or Device Component 3 3
Defective Device 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Premature Separation 2 2
Poor Quality Image 2 2
Application Program Problem 2 2
Material Separation 2 2
Material Fragmentation 2 2
Excess Flow or Over-Infusion 2 2
Device Sensing Problem 2 2
Defective Component 2 2
Improper or Incorrect Procedure or Method 1 1
Failure to Advance 1 1
Data Problem 1 1
Date/Time-Related Software Problem 1 1
Unintended Electrical Shock 1 1
Device Difficult to Program or Calibrate 1 1
Activation, Positioning or Separation Problem 1 1
No Apparent Adverse Event 1 1
Device Difficult to Setup or Prepare 1 1
Deflation Problem 1 1
Use of Device Problem 1 1
Smoking 1 1
Patient Device Interaction Problem 1 1
Failure to Power Up 1 1
Protective Measures Problem 1 1
Computer Operating System Problem 1 1
Air/Gas in Device 1 1
Physical Resistance/Sticking 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Alarm System 1 1
Impedance Problem 1 1
Device Damaged Prior to Use 1 1
Calibration Problem 1 1
Fluid/Blood Leak 1 1
Display or Visual Feedback Problem 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 50 50
Insufficient Information 23 23
Hemorrhage/Bleeding 14 14
Foreign Body In Patient 12 12
No Consequences Or Impact To Patient 11 11
Pain 8 8
Blood Loss 6 6
No Known Impact Or Consequence To Patient 6 6
Unspecified Tissue Injury 6 6
Epistaxis 5 5
Airway Obstruction 5 5
Discomfort 5 5
Injury 5 5
Sedation 4 4
Sore Throat 4 4
Tissue Damage 4 4
Obstruction/Occlusion 4 4
Nasal Obstruction 4 4
No Code Available 4 4
No Information 3 3
No Patient Involvement 3 3
Perforation of Esophagus 2 2
Radiation Exposure, Unintended 2 2
Convulsion/Seizure 2 2
Inflammation 2 2
Electric Shock 1 1
Laceration(s) of Esophagus 1 1
Bradycardia 1 1
Dyspnea 1 1
Hematoma 1 1
Pneumothorax 1 1
Scar Tissue 1 1
Failure of Implant 1 1
Unspecified Infection 1 1
Cough 1 1
Device Embedded In Tissue or Plaque 1 1
Patient Problem/Medical Problem 1 1

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