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TPLC
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Device
system, gastrointestinal motility (electrical)
Product Code
FFX
Regulation Number
876.1725
Device Class
2
Premarket Reviews
Manufacturer
Decision
ANX ROBOTICA CORP.
SUBSTANTIALLY EQUIVALENT
2
COVIDIEN LLC
SUBSTANTIALLY EQUIVALENT
2
CROSPON LTD
SUBSTANTIALLY EQUIVALENT
1
CROSPON LTD.
SUBSTANTIALLY EQUIVALENT
2
CROSPON, LTD.
SUBSTANTIALLY EQUIVALENT
4
DIVERSATEK HEALTHCARE
SUBSTANTIALLY EQUIVALENT
1
E-CATH CO., LTD
SUBSTANTIALLY EQUIVALENT
1
GIVEN IMAGING LTD.
SUBSTANTIALLY EQUIVALENT
1
KONSYL PHARMACEUTICALS
SUBSTANTIALLY EQUIVALENT
1
MEDICAL MEASUREMENT SYSTEMS,B.V.
SUBSTANTIALLY EQUIVALENT
1
MEDIFACTIA AB
SUBSTANTIALLY EQUIVALENT
2
MUI SCIENTIFIC
SUBSTANTIALLY EQUIVALENT
3
SIERRA SCIENTIFIC INSTRUMENTS, INC.
SUBSTANTIALLY EQUIVALENT
1
WILSON-COOK MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
4
4
2015
10
10
2016
15
15
2017
10
10
2018
17
17
2019
27
27
2020
20
20
2021
26
26
2022
31
31
2023
51
51
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Difficult to Remove
97
97
Material Integrity Problem
18
18
Adverse Event Without Identified Device or Use Problem
15
15
Material Deformation
10
10
Therapeutic or Diagnostic Output Failure
9
9
Insufficient Information
8
8
Device Displays Incorrect Message
7
7
Failure of Device to Self-Test
6
6
Device Operates Differently Than Expected
5
5
Patient-Device Incompatibility
5
5
Failure to Calibrate
5
5
Device Damaged Prior to Use
5
5
Break
5
5
Detachment of Device or Device Component
4
4
Pressure Problem
4
4
Material Split, Cut or Torn
3
3
Detachment Of Device Component
3
3
Labelling, Instructions for Use or Training Problem
3
3
Inadequacy of Device Shape and/or Size
3
3
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Material Separation
2
2
Sticking
2
2
Defective Component
2
2
Product Quality Problem
2
2
Defective Device
2
2
Poor Quality Image
2
2
Entrapment of Device
2
2
Material Fragmentation
2
2
Gradient Increase
2
2
Excess Flow or Over-Infusion
2
2
Premature Separation
2
2
Noise, Audible
2
2
Device Sensing Problem
2
2
Application Program Problem
2
2
Calibration Problem
2
2
Contamination /Decontamination Problem
1
1
Computer Operating System Problem
1
1
Loss of Data
1
1
Activation, Positioning or Separation Problem
1
1
Impedance Problem
1
1
Output Problem
1
1
Patient Device Interaction Problem
1
1
Data Problem
1
1
Protective Measures Problem
1
1
Torn Material
1
1
No Apparent Adverse Event
1
1
Air/Gas in Device
1
1
Physical Resistance/Sticking
1
1
Unintended Electrical Shock
1
1
Problem with Removal of Enzymatic Cleaner
1
1
Fluid/Blood Leak
1
1
Failure to Power Up
1
1
Device Difficult to Setup or Prepare
1
1
Inadequate Instructions for Healthcare Professional
1
1
Component Falling
1
1
Contamination
1
1
Crack
1
1
Deflation Problem
1
1
No Display/Image
1
1
Display or Visual Feedback Problem
1
1
Burst Container or Vessel
1
1
Device Reprocessing Problem
1
1
Device Alarm System
1
1
Loss of or Failure to Bond
1
1
Failure to Advance
1
1
Split
1
1
Physical Resistance
1
1
Date/Time-Related Software Problem
1
1
Device Inoperable
1
1
Use of Device Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Smoking
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
47
47
No Known Impact Or Consequence To Patient
25
25
Insufficient Information
23
23
Hemorrhage/Bleeding
15
15
Foreign Body In Patient
15
15
No Consequences Or Impact To Patient
12
12
No Code Available
11
11
Pain
11
11
Discomfort
10
10
Blood Loss
9
9
Injury
6
6
Unspecified Tissue Injury
6
6
Tissue Damage
5
5
Sedation
5
5
Airway Obstruction
5
5
No Information
5
5
Epistaxis
5
5
Obstruction/Occlusion
4
4
No Patient Involvement
4
4
Sore Throat
4
4
Nasal Obstruction
4
4
Radiation Exposure, Unintended
3
3
Perforation of Esophagus
3
3
Pneumothorax
3
3
Device Embedded In Tissue or Plaque
3
3
Convulsion/Seizure
2
2
Pulmonary Emphysema
2
2
Inflammation
2
2
Swelling
1
1
Bradycardia
1
1
Failure of Implant
1
1
Cough
1
1
Exposure to Body Fluids
1
1
Scar Tissue
1
1
Laceration(s)
1
1
Laceration(s) of Esophagus
1
1
Paralysis
1
1
Unspecified Infection
1
1
Rash
1
1
Patient Problem/Medical Problem
1
1
Electric Shock
1
1
Dyspnea
1
1
Hematoma
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Diversatek Healthcare
III
Sep-07-2023
2
Sandhill Scientific, Inc
II
May-07-2012
3
Sierra Scientific Instruments Inc
II
Oct-28-2011
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