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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
LABORIE MEDICAL TECHNOLOGIES CORP.
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
22
22
Device Problems
MDRs with this Device Problem
Events in those MDRs
Difficult to Remove
101
101
Material Integrity Problem
18
18
Adverse Event Without Identified Device or Use Problem
16
16
Material Deformation
12
12
Insufficient Information
11
11
Therapeutic or Diagnostic Output Failure
9
9
Device Displays Incorrect Message
7
7
Failure to Calibrate
6
6
Failure of Device to Self-Test
6
6
Device Operates Differently Than Expected
5
5
Patient-Device Incompatibility
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
Gradient Increase
3
3
Detachment Of Device Component
3
3
Inadequacy of Device Shape and/or Size
3
3
Poor Quality Image
3
3
Labelling, Instructions for Use or Training Problem
3
3
Product Quality Problem
3
3
Material Fragmentation
2
2
Smoking
2
2
Sticking
2
2
Defective Component
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Material Separation
2
2
Excess Flow or Over-Infusion
2
2
Entrapment of Device
2
2
Premature Separation
2
2
Noise, Audible
2
2
Defective Device
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
Failure to Advance
1
1
Split
1
1
Physical Resistance
1
1
Date/Time-Related Software Problem
1
1
Patient Device Interaction Problem
1
1
Data Problem
1
1
Air/Gas in Device
1
1
Physical Resistance/Sticking
1
1
Unintended Electrical Shock
1
1
Protective Measures Problem
1
1
Torn Material
1
1
No Apparent Adverse Event
1
1
Impedance Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Output Problem
1
1
Problem with Removal of Enzymatic Cleaner
1
1
Fluid/Blood Leak
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
Component Falling
1
1
Contamination
1
1
Intermittent Continuity
1
1
Crack
1
1
Deflation Problem
1
1
No Display/Image
1
1
Display or Visual Feedback Problem
1
1
Device Inoperable
1
1
Use of Device Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Inadequate Instructions for Healthcare Professional
1
1
Failure to Power Up
1
1
Device Difficult to Setup or Prepare
1
1
Device Difficult to Program or Calibrate
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
62
62
No Known Impact Or Consequence To Patient
25
25
Insufficient Information
23
23
Foreign Body In Patient
16
16
Hemorrhage/Bleeding
16
16
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
No Information
5
5
Epistaxis
5
5
Sedation
5
5
Tissue Damage
5
5
Airway Obstruction
5
5
Obstruction/Occlusion
4
4
Nasal Obstruction
4
4
Sore Throat
4
4
No Patient Involvement
4
4
Radiation Exposure, Unintended
3
3
Device Embedded In Tissue or Plaque
3
3
Perforation of Esophagus
3
3
Laceration(s)
3
3
Pneumothorax
3
3
Inflammation
2
2
Pulmonary Emphysema
2
2
Laceration(s) of Esophagus
2
2
Convulsion/Seizure
2
2
Cough
1
1
Patient Problem/Medical Problem
1
1
Electric Shock
1
1
Hematoma
1
1
Failure of Implant
1
1
Unspecified Infection
1
1
Exposure to Body Fluids
1
1
Bradycardia
1
1
Dyspnea
1
1
Paralysis
1
1
Rash
1
1
Scar Tissue
1
1
Swelling
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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