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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
2019 621 621
2020 770 770
2021 516 516
2022 260 260
2023 259 259
2024 54 54

Device Problems MDRs with this Device Problem Events in those MDRs
Positioning Failure 1430 1430
Loss of or Failure to Bond 644 644
Detachment of Device or Device Component 171 171
Failure to Transmit Record 103 103
Entrapment of Device 64 64
Separation Failure 51 51
Unintended Application Program Shut Down 46 46
Insufficient Information 44 44
Adverse Event Without Identified Device or Use Problem 34 34
Signal Artifact/Noise 18 18
Activation, Positioning or Separation Problem 16 16
Activation Problem 15 15
Break 13 13
Difficult or Delayed Separation 12 12
Loss of Data 11 11
Loss of Power 11 11
Failure to Power Up 8 8
Data Problem 8 8
Activation Failure 8 8
Material Twisted/Bent 6 6
Malposition of Device 5 5
Failure to Advance 5 5
High pH 5 5
Defective Device 4 4
Poor Quality Image 4 4
Calibration Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Premature Separation 4 4
Physical Resistance/Sticking 3 3
Low pH 3 3
Device Dislodged or Dislocated 3 3
Connection Problem 3 3
Failure to Calibrate 3 3
Use of Device Problem 3 3
Unexpected Shutdown 3 3
Difficult to Remove 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Device Alarm System 2 2
Device Slipped 2 2
Loose or Intermittent Connection 2 2
Mechanical Problem 2 2
Migration or Expulsion of Device 2 2
No Display/Image 2 2
Failure to Fire 2 2
Blocked Connection 2 2
Material Integrity Problem 2 2
Patient Device Interaction Problem 2 2
Migration 2 2
Noise, Audible 2 2
Separation Problem 2 2
Device Fell 1 1
Complete Loss of Power 1 1
Inaccurate Information 1 1
Key or Button Unresponsive/not Working 1 1
Wireless Communication Problem 1 1
Firing Problem 1 1
Mechanics Altered 1 1
Unintended Movement 1 1
Output Problem 1 1
Communication or Transmission Problem 1 1
Display or Visual Feedback Problem 1 1
Material Fragmentation 1 1
Crack 1 1
Premature Discharge of Battery 1 1
Nonstandard Device 1 1
Premature Activation 1 1
Unable to Obtain Readings 1 1
Failure to Align 1 1
Device Displays Incorrect Message 1 1
Misfire 1 1
Failure to Sense 1 1
Inadequacy of Device Shape and/or Size 1 1
Failure to Reset 1 1
Improper or Incorrect Procedure or Method 1 1
Suction Problem 1 1
Defective Component 1 1
Component Missing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1030 1030
No Clinical Signs, Symptoms or Conditions 693 693
Foreign Body In Patient 270 270
Airway Obstruction 268 268
No Information 69 69
Insufficient Information 57 57
Aspiration/Inhalation 54 54
Injury 39 39
Chest Pain 37 37
No Known Impact Or Consequence To Patient 36 36
Pain 30 30
Laceration(s) of Esophagus 23 23
Unintended Radiation Exposure 23 23
Radiation Exposure, Unintended 22 22
No Code Available 17 17
Sedation 17 17
Oversedation 17 17
Hemorrhage/Bleeding 11 11
Cough 11 11
Discomfort 10 10
Failure of Implant 8 8
Unspecified Tissue Injury 8 8
Blood Loss 8 8
Sore Throat 7 7
Tissue Damage 6 6
Vomiting 6 6
Dysphagia/ Odynophagia 6 6
Dyspnea 5 5
Ulcer 4 4
Laceration(s) 4 4
Nausea 4 4
Inflammation 3 3
No Patient Involvement 3 3
Low Oxygen Saturation 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Hypoxia 2 2
Fever 2 2
Abdominal Pain 2 2
Pyrosis/Heartburn 2 2
Asthma 2 2
Bradycardia 1 1
Burn(s) 1 1
Cyanosis 1 1
Diarrhea 1 1
Awareness during Anaesthesia 1 1
Apnea 1 1
Low Blood Pressure/ Hypotension 1 1
Foreign Body Sensation in Eye 1 1
Perforation 1 1
Respiratory Distress 1 1
Hernia 1 1
Chills 1 1
Dizziness 1 1
Ulceration 1 1
Swelling/ Edema 1 1
Respiratory Insufficiency 1 1
Bowel Perforation 1 1
Constipation 1 1
Device Embedded In Tissue or Plaque 1 1
Not Applicable 1 1
Malaise 1 1
Perforation of Esophagus 1 1
Reaction 1 1
Respiratory Tract Infection 1 1
Choking 1 1
Nasal Obstruction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Covidien Llc II Apr-01-2021
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