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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
Material Deformation 10 10
Insufficient Information 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
Break 3 3
Inadequacy of Device Shape and/or Size 3 3
Material Split, Cut or Torn 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Defective Device 3 3
Device Displays Incorrect Message 3 3
Device Difficult to Program or Calibrate 3 3
Detachment of Device or Device Component 3 3
Gradient Increase 3 3
Fluid/Blood Leak 2 2
Smoking 2 2
No Apparent Adverse Event 2 2
Premature Separation 2 2
Product Quality Problem 2 2
Activation, Positioning or Separation Problem 2 2
Device Sensing Problem 2 2
Excess Flow or Over-Infusion 2 2
Defective Component 1 1
Device Damaged Prior to Use 1 1
Improper or Incorrect Procedure or Method 1 1
Use of Device Problem 1 1
Material Separation 1 1
Failure to Sense 1 1
Material Rupture 1 1
Material Puncture/Hole 1 1
Device Difficult to Setup or Prepare 1 1
Difficult to Insert 1 1
Inflation Problem 1 1
Impedance Problem 1 1
Computer Operating System Problem 1 1
Calibration Problem 1 1
Sparking 1 1
Air/Gas in Device 1 1
Failure to Deflate 1 1
Unintended Electrical Shock 1 1
Physical Resistance/Sticking 1 1
Patient Device Interaction Problem 1 1
Data Problem 1 1
Protective Measures Problem 1 1
Output Problem 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
Discomfort 5 5
Injury 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
Blood Loss 2 2
Convulsion/Seizure 2 2
Cough 2 2
Laceration(s) 2 2
Pneumothorax 2 2
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
Dyspnea 1 1
Hematoma 1 1
Failure of Implant 1 1
Unspecified Infection 1 1
Inflammation 1 1
Laceration(s) of Esophagus 1 1
Perforation of Esophagus 1 1
Electric Shock 1 1
Perforation 1 1
Pneumonia 1 1
Scar Tissue 1 1
Vomiting 1 1

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