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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrode, ph, stomach
Product CodeFFT
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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