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TPLC
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show TPLC since
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2024
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Device
system, imaging, gastrointestinal, wireless, capsule
Product Code
NEZ
Regulation Number
876.1300
Device Class
2
Premarket Reviews
Manufacturer
Decision
ANKON TECHNOLOGIES CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
ANX ROBOTICA CORPORATION
SUBSTANTIALLY EQUIVALENT
1
CAPSOVISION, INC.
SUBSTANTIALLY EQUIVALENT
2
GIVEN IMAGING LTD. (D.B.A. MEDTRONIC)
SUBSTANTIALLY EQUIVALENT
1
GIVEN IMAGING LTD. (MEDTRONIC)
SUBSTANTIALLY EQUIVALENT
2
OLYMPUS MEDICAL SYSTEMS CORP.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
56
56
2020
31
31
2021
41
41
2022
63
63
2023
34
34
2024
76
76
Device Problems
MDRs with this Device Problem
Events in those MDRs
Entrapment of Device
104
104
Adverse Event Without Identified Device or Use Problem
80
80
Output Problem
24
24
Insufficient Information
17
17
Unintended Application Program Shut Down
12
12
Human-Device Interface Problem
11
11
Break
7
7
Detachment of Device or Device Component
6
6
Inadequacy of Device Shape and/or Size
5
5
Failure to Transmit Record
5
5
Activation, Positioning or Separation Problem
4
4
Activation Problem
4
4
Material Fragmentation
4
4
Loss of Power
3
3
Therapeutic or Diagnostic Output Failure
3
3
Data Problem
3
3
Difficult to Remove
3
3
Device Handling Problem
2
2
Defective Device
2
2
Patient Device Interaction Problem
2
2
Positioning Problem
2
2
Patient-Device Incompatibility
2
2
Communication or Transmission Problem
2
2
Failure to Fire
2
2
Signal Artifact/Noise
2
2
Material Protrusion/Extrusion
2
2
Use of Device Problem
1
1
Computer Operating System Problem
1
1
Deflation Problem
1
1
Failure to Clean Adequately
1
1
Image Display Error/Artifact
1
1
Poor Quality Image
1
1
No Display/Image
1
1
Crack
1
1
No Apparent Adverse Event
1
1
Activation Failure
1
1
Failure to Read Input Signal
1
1
Unexpected Therapeutic Results
1
1
Mechanical Jam
1
1
Improper or Incorrect Procedure or Method
1
1
Premature Discharge of Battery
1
1
Separation Problem
1
1
Loss of Data
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Foreign Body In Patient
134
134
No Clinical Signs, Symptoms or Conditions
49
49
Radiation Exposure, Unintended
30
30
Abdominal Pain
20
20
Unintended Radiation Exposure
18
18
No Known Impact Or Consequence To Patient
17
17
No Consequences Or Impact To Patient
13
13
Insufficient Information
13
13
Obstruction/Occlusion
11
11
Vomiting
8
8
Discomfort
6
6
Injury
6
6
No Information
6
6
Aspiration/Inhalation
6
6
Nausea
4
4
Unspecified Gastrointestinal Problem
4
4
Inflammation
4
4
Perforation
4
4
Pain
3
3
Diarrhea
3
3
Burning Sensation
3
3
No Code Available
3
3
Death
3
3
Foreign Body Reaction
2
2
Failure of Implant
2
2
Hypersensitivity/Allergic reaction
2
2
Dyspnea
2
2
Stenosis
2
2
Cough
2
2
Weight Changes
2
2
Low Blood Pressure/ Hypotension
2
2
Low Oxygen Saturation
2
2
Tissue Breakdown
2
2
Ischemia
1
1
Abdominal Distention
1
1
Pyrosis/Heartburn
1
1
Laceration(s) of Esophagus
1
1
Bowel Perforation
1
1
Blister
1
1
Peritonitis
1
1
Fever
1
1
Rash
1
1
Sepsis
1
1
Complaint, Ill-Defined
1
1
Chest Pain
1
1
Erythema
1
1
Hernia
1
1
Infarction, Cerebral
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Laceration(s)
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Capso Vision, Inc.
II
Jul-08-2020
2
Capso Vision, Inc.
II
May-21-2020
3
Capso Vision, Inc.
II
Apr-30-2020
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