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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
Poor Quality Image 4 4
Pressure Problem 4 4
Defective Device 3 3
Device Displays Incorrect Message 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Device Difficult to Program or Calibrate 3 3
Detachment of Device or Device Component 3 3
Gradient Increase 3 3
Material Split, Cut or Torn 3 3
Inadequacy of Device Shape and/or Size 3 3
Break 3 3
Product Quality Problem 2 2
Excess Flow or Over-Infusion 2 2
Premature Separation 2 2
No Apparent Adverse Event 2 2
Fluid/Blood Leak 2 2
Smoking 2 2
Device Sensing Problem 2 2
Activation, Positioning or Separation Problem 2 2
Display or Visual Feedback Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Deflation Problem 1 1
Intermittent Continuity 1 1
Defective Component 1 1
Output Problem 1 1
Device Damaged Prior to Use 1 1
Protective Measures Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Use of Device Problem 1 1
Data Problem 1 1
Patient Device Interaction Problem 1 1
Material Separation 1 1
Physical Resistance/Sticking 1 1
Unintended Electrical Shock 1 1
Failure to Sense 1 1
Failure to Deflate 1 1
Air/Gas in Device 1 1
Material Rupture 1 1
Inflation Problem 1 1
Impedance Problem 1 1
Difficult to Insert 1 1
Device Difficult to Setup or Prepare 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
Pain 9 9
Foreign Body In Patient 9 9
Airway Obstruction 7 7
Unspecified Tissue Injury 6 6
Discomfort 5 5
Injury 5 5
Epistaxis 5 5
Sore Throat 4 4
Obstruction/Occlusion 4 4
Nasal Obstruction 4 4
Tissue Damage 4 4
No Consequences Or Impact To Patient 4 4
Sedation 3 3
Laceration(s) 2 2
Pneumothorax 2 2
Blood Loss 2 2
Convulsion/Seizure 2 2
Cough 2 2
Laceration(s) of Esophagus 1 1
Perforation of Esophagus 1 1
Electric Shock 1 1
Dyspnea 1 1
Hematoma 1 1
Failure of Implant 1 1
Unspecified Infection 1 1
Inflammation 1 1
Perforation 1 1
Pneumonia 1 1
Scar Tissue 1 1
Vomiting 1 1
No Patient Involvement 1 1
Patient Problem/Medical Problem 1 1
No Known Impact Or Consequence To Patient 1 1
No Information 1 1
No Code Available 1 1

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