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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)
Regulation Description Gastrointestinal motility monitoring system.
Product CodeFFX
Regulation Number 876.1725
Device Class 2


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

MDR Year MDR Reports MDR Events
2020 20 20
2021 26 26
2022 31 31
2023 51 51
2024 59 59
2025 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Remove 78 78
Material Integrity Problem 18 18
Adverse Event Without Identified Device or Use Problem 11 11
Insufficient Information 10 10
Material Deformation 10 10
Therapeutic or Diagnostic Output Failure 8 8
Failure of Device to Self-Test 6 6
Failure to Calibrate 5 5
Pressure Problem 4 4
Poor Quality Image 4 4
Gradient Increase 3 3
Material Split, Cut or Torn 3 3
Break 3 3
Device Displays Incorrect Message 3 3
Defective Device 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Detachment of Device or Device Component 3 3
Inadequacy of Device Shape and/or Size 3 3
Device Difficult to Program or Calibrate 3 3
Activation, Positioning or Separation Problem 2 2
Fluid/Blood Leak 2 2
Premature Separation 2 2
Smoking 2 2
No Apparent Adverse Event 2 2
Device Sensing Problem 2 2
Excess Flow or Over-Infusion 2 2
Product Quality Problem 2 2
Improper or Incorrect Procedure or Method 1 1
Display or Visual Feedback Problem 1 1
Failure to Deflate 1 1
Intermittent Continuity 1 1
Protective Measures Problem 1 1
Material Separation 1 1
Data Problem 1 1
Computer Operating System Problem 1 1
Calibration Problem 1 1
Material Rupture 1 1
Inflation Problem 1 1
Use of Device Problem 1 1
Device Difficult to Setup or Prepare 1 1
Impedance Problem 1 1
Difficult to Insert 1 1
Air/Gas in Device 1 1
Patient Device Interaction Problem 1 1
Deflation Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Defective Component 1 1
Failure to Sense 1 1
Material Puncture/Hole 1 1
Unintended Electrical Shock 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 104 104
Insufficient Information 32 32
Hemorrhage/Bleeding 17 17
Foreign Body In Patient 9 9
Pain 9 9
Airway Obstruction 7 7
Unspecified Tissue Injury 6 6
Epistaxis 5 5
Injury 5 5
Discomfort 5 5
Obstruction/Occlusion 4 4
Nasal Obstruction 4 4
Tissue Damage 4 4
No Consequences Or Impact To Patient 4 4
Sore Throat 4 4
Sedation 3 3
Pneumothorax 2 2
Blood Loss 2 2
Laceration(s) 2 2
Cough 2 2
Convulsion/Seizure 2 2
Unspecified Infection 1 1
Patient Problem/Medical Problem 1 1
Electric Shock 1 1
Failure of Implant 1 1
No Code Available 1 1
Perforation of Esophagus 1 1
No Information 1 1
Hematoma 1 1
Inflammation 1 1
Perforation 1 1
Laceration(s) of Esophagus 1 1
No Known Impact Or Consequence To Patient 1 1
Vomiting 1 1
No Patient Involvement 1 1
Dyspnea 1 1
Scar Tissue 1 1
Pneumonia 1 1

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