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TPLC
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show TPLC since
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2024
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Device
insufflator, automatic carbon-dioxide for endoscope
Product Code
FCX
Regulation Number
876.1500
Device Class
2
Premarket Reviews
Manufacturer
Decision
BARONOVA, INC.
SUBSTANTIALLY EQUIVALENT - KIT
1
BRACCO DIAGNOSTIC, INC.
SUBSTANTIALLY EQUIVALENT
3
BYRNE MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
FUJIFILM CORPORATION
SUBSTANTIALLY EQUIVALENT
1
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
SUBSTANTIALLY EQUIVALENT
1
KARL STORZ ENDOSCOPY AMERICA, INC.
SUBSTANTIALLY EQUIVALENT
1
LEXION MEDICAL, LLC.
SUBSTANTIALLY EQUIVALENT
1
NEXCORE TECHNOLOGY, LLC
SUBSTANTIALLY EQUIVALENT
1
PALLIARE LTD.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
10
10
2015
5
5
2016
4
4
2017
3
3
2018
7
7
2019
4
4
2020
1
1
2021
12
12
2022
29
29
2023
54
54
2024
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
29
29
Pressure Problem
20
20
No Apparent Adverse Event
15
15
Pumping Stopped
14
14
Device Handling Problem
12
12
Device Alarm System
11
11
Adverse Event Without Identified Device or Use Problem
10
10
Burst Container or Vessel
5
5
Device Reprocessing Problem
4
4
Infusion or Flow Problem
4
4
Air Leak
3
3
Noise, Audible
3
3
Material Rupture
3
3
Defective Component
3
3
Inflation Problem
3
3
Deflation Problem
2
2
No Display/Image
2
2
Obstruction of Flow
2
2
Malposition of Device
2
2
Device Inoperable
2
2
Use of Device Problem
2
2
Improper or Incorrect Procedure or Method
2
2
Patient Device Interaction Problem
2
2
Complete Loss of Power
2
2
Unexpected Shutdown
2
2
Activation Problem
2
2
Failure to Clean Adequately
1
1
Unintended Electrical Shock
1
1
Explosion
1
1
Therapeutic or Diagnostic Output Failure
1
1
Sensing Intermittently
1
1
Contamination /Decontamination Problem
1
1
Extrusion
1
1
Improper Flow or Infusion
1
1
Inaccurate Flow Rate
1
1
Gas Output Problem
1
1
Intermittent Continuity
1
1
Use of Incorrect Control/Treatment Settings
1
1
Crack
1
1
Difficult to Insert
1
1
Leak/Splash
1
1
Misconnection
1
1
Loss of Power
1
1
Failure to Power Up
1
1
Low Audible Alarm
1
1
Break
1
1
Product Quality Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
73
73
Insufficient Information
22
22
Abdominal Pain
8
8
No Consequences Or Impact To Patient
7
7
Bowel Perforation
7
7
Bradycardia
5
5
No Known Impact Or Consequence To Patient
4
4
Perforation
3
3
Hemorrhage/Bleeding
2
2
Inflammation
2
2
Cardiac Arrest
2
2
No Information
2
2
Air Embolism
2
2
No Code Available
1
1
Test Result
1
1
Peritonitis
1
1
Discomfort
1
1
Perforation of Esophagus
1
1
Reaction
1
1
Electric Shock
1
1
Abdominal Distention
1
1
Death
1
1
Embolism
1
1
Fever
1
1
Bowel Burn
1
1
Abscess
1
1
Pain
1
1
Low Blood Pressure/ Hypotension
1
1
Respiratory Distress
1
1
Therapeutic Effects, Unexpected
1
1
Tissue Damage
1
1
Vomiting
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Northgate Technologies, Inc.
II
Feb-24-2021
2
Pentax Medical Company
I
Oct-28-2013
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