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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 233 233

Device Problems MDRs with this Device Problem Events in those MDRs
Positioning Failure 1391 1391
Loss of or Failure to Bond 785 785
Failure To Adhere Or Bond 486 486
Detachment of Device or Device Component 213 213
Failure to Transmit Record 113 113
Detachment Of Device Component 89 89
Entrapment of Device 80 80
Unintended Application Program Shut Down 61 61
Insufficient Information 50 50
Adverse Event Without Identified Device or Use Problem 45 45
Communication or Transmission Problem 43 43
Separation Failure 41 41
Signal Artifact/Noise 31 31
Activation, Positioning or Separation Problem 21 21
Loss of Data 19 19
High pH 19 19
Break 16 16
Loss of Power 15 15
Device Operates Differently Than Expected 15 15
Activation Problem 15 15
Failure to Power Up 12 12
Failure to Calibrate 11 11
Device Displays Incorrect Message 11 11
Difficult or Delayed Separation 11 11
Data Problem 10 10
Appropriate Term/Code Not Available 9 9
Misconnection 9 9
Poor Quality Image 8 8
Activation Failure 8 8
Missing Test Results 6 6
Mechanical Problem 6 6
Failure to Advance 6 6
Defective Device 6 6
Connection Problem 6 6
Material Twisted/Bent 6 6
Malposition of Device 5 5
Calibration Problem 5 5
Device Fell 5 5
Noise, Audible 4 4
Therapeutic or Diagnostic Output Failure 4 4
Premature Separation 4 4
Separation Problem 4 4
Physical Resistance/Sticking 4 4
Failure to Fire 4 4
Material Integrity Problem 4 4
Difficult to Remove 4 4
Device Alarm System 3 3
Failure to Sense 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
Device Dislodged or Dislocated 3 3
Device Slipped 3 3
Unexpected Shutdown 3 3
Positioning Problem 3 3
Low pH 3 3
Firing Problem 2 2
Patient Device Interaction Problem 2 2
Migration 2 2
Misfire 2 2
Date/Time-Related Software Problem 2 2
Chemical Problem 2 2
Blocked Connection 2 2
Material Distortion 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Off-Label Use 2 2
Unable to Obtain Readings 1 1
Failure to Reset 1 1
Nonstandard Device 1 1
Premature Activation 1 1
Inadequacy of Device Shape and/or Size 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
Display or Visual Feedback Problem 1 1
Material Fragmentation 1 1
Grounding Malfunction 1 1
Premature Discharge of Battery 1 1
Component Falling 1 1
Crack 1 1
Material Discolored 1 1
Mechanics Altered 1 1
Output Problem 1 1
Data Back-Up Problem 1 1
Device-Device Incompatibility 1 1
Difficult to Open or Close 1 1
Low Battery 1 1
Inaccurate Synchronization 1 1
High Readings 1 1
Structural Problem 1 1
Failure to Align 1 1
Wireless Communication Problem 1 1
Complete Loss of Power 1 1
Protective Measures Problem 1 1
Unintended Movement 1 1
Inaccurate Information 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 651 651
Airway Obstruction 257 257
Foreign Body In Patient 241 241
No Known Impact Or Consequence To Patient 199 199
No Information 73 73
Aspiration/Inhalation 59 59
Insufficient Information 57 57
Chest Pain 44 44
Injury 42 42
Pain 39 39
Radiation Exposure, Unintended 38 38
Unintended Radiation Exposure 23 23
Laceration(s) of Esophagus 23 23
No Code Available 20 20
Sedation 17 17
Oversedation 17 17
No Patient Involvement 16 16
Discomfort 14 14
Hemorrhage/Bleeding 13 13
Cough 11 11
Blood Loss 9 9
Unspecified Tissue Injury 8 8
Vomiting 8 8
Failure of Implant 7 7
Sore Throat 7 7
Tissue Damage 7 7
Dysphagia/ Odynophagia 6 6
Dyspnea 5 5
Nausea 5 5
Laceration(s) 4 4
Inflammation 3 3
Abdominal Pain 3 3
Ulcer 3 3
Perforation of Esophagus 3 3
Choking 2 2
Swelling 2 2
Low Oxygen Saturation 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
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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
Swelling/ Edema 1 1
Respiratory Insufficiency 1 1
Constipation 1 1
Malaise 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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