• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Remove 77 77
Material Integrity Problem 18 18
Adverse Event Without Identified Device or Use Problem 11 11
Material Deformation 10 10
Insufficient Information 9 9
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
Device Displays Incorrect Message 3 3
Inadequacy of Device Shape and/or Size 3 3
Material Split, Cut or Torn 3 3
Defective Device 3 3
Gradient Increase 3 3
Detachment of Device or Device Component 3 3
Excess Flow or Over-Infusion 2 2
Premature Separation 2 2
Device Sensing Problem 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Product Quality Problem 2 2
Device Difficult to Program or Calibrate 2 2
Smoking 2 2
No Apparent Adverse Event 2 2
Break 2 2
Patient Device Interaction Problem 1 1
Intermittent Continuity 1 1
Data Problem 1 1
Deflation Problem 1 1
Protective Measures Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Defective Component 1 1
Device Difficult to Setup or Prepare 1 1
Computer Operating System Problem 1 1
Impedance Problem 1 1
Physical Resistance/Sticking 1 1
Calibration Problem 1 1
Material Separation 1 1
Device Damaged Prior to Use 1 1
Air/Gas in Device 1 1
Fluid/Blood Leak 1 1
Unintended Electrical Shock 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Display or Visual Feedback Problem 1 1
Output Problem 1 1
Activation, Positioning or Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 94 94
Insufficient Information 30 30
Hemorrhage/Bleeding 17 17
Foreign Body In Patient 9 9
Pain 8 8
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
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
Dyspnea 1 1
Hematoma 1 1
Failure of Implant 1 1
Unspecified Infection 1 1
Inflammation 1 1

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