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TPLC
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Device
system, gastrointestinal motility (electrical)
Regulation Description
Gastrointestinal motility monitoring system.
Product Code
FFX
Regulation Number
876.1725
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
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