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TPLC
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show TPLC since
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Device
electrode, ph, stomach
Product Code
FFT
Regulation Number
876.1400
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
955
955
2019
621
621
2020
770
770
2021
516
516
2022
260
260
2023
25
25
Device Problems
MDRs with this Device Problem
Events in those MDRs
Positioning Failure
1249
1249
Loss of or Failure to Bond
785
785
Failure To Adhere Or Bond
486
486
Detachment of Device or Device Component
212
212
Failure to Transmit Record
92
92
Detachment Of Device Component
89
89
Entrapment of Device
75
75
Unintended Application Program Shut Down
57
57
Communication or Transmission Problem
43
43
Insufficient Information
42
42
Adverse Event Without Identified Device or Use Problem
41
41
Signal Artifact/Noise
31
31
Activation, Positioning or Separation Problem
20
20
High pH
19
19
Separation Failure
19
19
Loss of Data
18
18
Device Operates Differently Than Expected
15
15
Loss of Power
15
15
Break
14
14
Activation Problem
14
14
Failure to Power Up
12
12
Failure to Calibrate
11
11
Device Displays Incorrect Message
11
11
Data Problem
10
10
Difficult or Delayed Separation
10
10
Appropriate Term/Code Not Available
9
9
Misconnection
9
9
Poor Quality Image
8
8
Activation Failure
7
7
Missing Test Results
6
6
Mechanical Problem
6
6
Failure to Advance
6
6
Malposition of Device
5
5
Connection Problem
5
5
Calibration Problem
5
5
Material Twisted/Bent
5
5
Material Integrity Problem
4
4
Failure to Fire
4
4
Difficult to Remove
4
4
Noise, Audible
4
4
Separation Problem
4
4
Physical Resistance/Sticking
4
4
Device Fell
4
4
Premature Separation
4
4
Unexpected Shutdown
3
3
Low pH
3
3
Therapeutic or Diagnostic Output Failure
3
3
Device Alarm System
3
3
Failure to Sense
3
3
Device Slipped
3
3
Use of Device Problem
3
3
Migration or Expulsion of Device
3
3
Image Resolution Poor
3
3
Loose or Intermittent Connection
3
3
No Display/Image
3
3
Positioning Problem
3
3
Defective Device
3
3
Device Dislodged or Dislocated
3
3
Material Distortion
2
2
Blocked Connection
2
2
Chemical Problem
2
2
Misfire
2
2
Date/Time-Related Software Problem
2
2
Off-Label Use
2
2
Firing Problem
2
2
Patient Device Interaction Problem
2
2
Migration
2
2
Complete Loss of Power
1
1
Unintended Movement
1
1
Wireless Communication Problem
1
1
Key or Button Unresponsive/not Working
1
1
Inaccurate Synchronization
1
1
Improper or Incorrect Procedure or Method
1
1
Suction Problem
1
1
Defective Component
1
1
Component Missing
1
1
Failure to Deliver
1
1
Failure to Reset
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Nonstandard Device
1
1
Premature Activation
1
1
Display or Visual Feedback Problem
1
1
Grounding Malfunction
1
1
Component Falling
1
1
Crack
1
1
Material Discolored
1
1
Low Battery
1
1
High Readings
1
1
Structural Problem
1
1
Failure to Align
1
1
Data Back-Up Problem
1
1
Device-Device Incompatibility
1
1
Difficult to Open or Close
1
1
Protective Measures Problem
1
1
Output Problem
1
1
Mechanics Altered
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
1808
1808
No Clinical Signs, Symptoms or Conditions
566
566
Airway Obstruction
228
228
No Known Impact Or Consequence To Patient
199
199
Foreign Body In Patient
156
156
No Information
73
73
Aspiration/Inhalation
56
56
Insufficient Information
54
54
Injury
42
42
Chest Pain
40
40
Pain
39
39
Radiation Exposure, Unintended
38
38
Laceration(s) of Esophagus
23
23
Unintended Radiation Exposure
21
21
No Code Available
20
20
Sedation
17
17
Oversedation
17
17
No Patient Involvement
16
16
Discomfort
11
11
Blood Loss
9
9
Cough
9
9
Unspecified Tissue Injury
8
8
Vomiting
8
8
Hemorrhage/Bleeding
8
8
Sore Throat
7
7
Tissue Damage
7
7
Dysphagia/ Odynophagia
6
6
Dyspnea
5
5
Nausea
5
5
Failure of Implant
5
5
Laceration(s)
4
4
Inflammation
3
3
Abdominal Pain
3
3
Ulcer
3
3
Perforation of Esophagus
3
3
Low Oxygen Saturation
2
2
Choking
2
2
Swelling
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Device Embedded In Tissue or Plaque
2
2
Asthma
2
2
Fever
2
2
Foreign Body Sensation in Eye
2
2
Pyrosis/Heartburn
2
2
Hypoxia
2
2
Itching Sensation
1
1
Unspecified Infection
1
1
Burning Sensation
1
1
Tingling
1
1
Chills
1
1
Cramp(s)
1
1
Dizziness
1
1
Perforation
1
1
Rash
1
1
Respiratory Distress
1
1
Low Blood Pressure/ Hypotension
1
1
Cyanosis
1
1
Diarrhea
1
1
Bradycardia
1
1
Burn(s)
1
1
Vessel Or Plaque, Device Embedded In
1
1
Awareness during Anaesthesia
1
1
Apnea
1
1
Not Applicable
1
1
Tissue Breakdown
1
1
Respiratory Insufficiency
1
1
Constipation
1
1
Ulceration
1
1
Hernia
1
1
Cardiogenic Shock
1
1
Nasal Obstruction
1
1
Reaction
1
1
Respiratory Tract Infection
1
1
Neck Pain
1
1
Sweating
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Covidien Llc
II
Apr-01-2021
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