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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
38
38
Device Problems
MDRs with this Device Problem
Events in those MDRs
Difficult to Remove
103
103
Material Integrity Problem
18
18
Adverse Event Without Identified Device or Use Problem
17
17
Material Deformation
12
12
Insufficient Information
11
11
Therapeutic or Diagnostic Output Failure
9
9
Device Displays Incorrect Message
7
7
Failure of Device to Self-Test
6
6
Failure to Calibrate
6
6
Break
5
5
Device Damaged Prior to Use
5
5
Patient-Device Incompatibility
5
5
Device Operates Differently Than Expected
5
5
Poor Quality Image
4
4
Pressure Problem
4
4
Detachment of Device or Device Component
4
4
Product Quality Problem
4
4
Material Split, Cut or Torn
3
3
Defective Device
3
3
Gradient Increase
3
3
Detachment Of Device Component
3
3
Inadequacy of Device Shape and/or Size
3
3
Labelling, Instructions for Use or Training Problem
3
3
Noise, Audible
2
2
Device Sensing Problem
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Excess Flow or Over-Infusion
2
2
Sticking
2
2
Smoking
2
2
Material Fragmentation
2
2
Material Separation
2
2
Device Difficult to Program or Calibrate
2
2
Calibration Problem
2
2
Premature Separation
2
2
Defective Component
2
2
Application Program Problem
2
2
Entrapment of Device
2
2
Device Reprocessing Problem
1
1
Failure to Advance
1
1
Protective Measures Problem
1
1
Physical Resistance
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Intermittent Continuity
1
1
Device Inoperable
1
1
Loss of Data
1
1
Improper or Incorrect Procedure or Method
1
1
Display or Visual Feedback Problem
1
1
Unintended Electrical Shock
1
1
Device Alarm System
1
1
Crack
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
72
72
Insufficient Information
28
28
No Known Impact Or Consequence To Patient
25
25
Hemorrhage/Bleeding
18
18
Foreign Body In Patient
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
Unspecified Tissue Injury
6
6
Injury
6
6
Airway Obstruction
5
5
No Information
5
5
Tissue Damage
5
5
Sedation
5
5
Epistaxis
5
5
Pneumothorax
4
4
Sore Throat
4
4
Nasal Obstruction
4
4
Obstruction/Occlusion
4
4
No Patient Involvement
4
4
Device Embedded In Tissue or Plaque
3
3
Laceration(s)
3
3
Perforation of Esophagus
3
3
Radiation Exposure, Unintended
3
3
Laceration(s) of Esophagus
2
2
Inflammation
2
2
Pulmonary Emphysema
2
2
Convulsion/Seizure
2
2
Exposure to Body Fluids
1
1
Swelling
1
1
Paralysis
1
1
Rash
1
1
Perforation
1
1
Scar Tissue
1
1
Dyspnea
1
1
Hematoma
1
1
Bradycardia
1
1
Pneumonia
1
1
Cough
1
1
Failure of Implant
1
1
Electric Shock
1
1
Unspecified Infection
1
1
Patient Problem/Medical Problem
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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