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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


Premarket Reviews
ManufacturerDecision
GIVEN IMAGING LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 306 306
2015 346 346
2016 472 472
2017 884 884
2018 955 955
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
Failure To Adhere Or Bond 1928 1928
Positioning Failure 1853 1853
Loss of or Failure to Bond 804 804
Detachment of Device or Device Component 237 237
Communication or Transmission Problem 159 159
Failure to Transmit Record 154 154
Device Operates Differently Than Expected 133 133
Detachment Of Device Component 114 114
Entrapment of Device 107 107
Adverse Event Without Identified Device or Use Problem 89 89
Separation Failure 64 64
Unintended Application Program Shut Down 61 61
Connection Problem 56 56
Insufficient Information 54 54
Difficult or Delayed Positioning 40 40
Signal Artifact/Noise 31 31
Device Displays Incorrect Message 31 31
High pH 30 30
Activation, Positioning or Separation Problem 24 24
Loss of Data 21 21
Data Problem 20 20
Missing Test Results 20 20
Break 20 20
Failure to Calibrate 16 16
Loss of Power 15 15
Failure to Power Up 15 15
Activation Problem 15 15
Difficult or Delayed Separation 12 12
Poor Quality Image 12 12
Misconnection 9 9
Calibration Problem 9 9
Appropriate Term/Code Not Available 9 9
Activation Failure 8 8
Malposition of Device 8 8
Incorrect, Inadequate or Imprecise Result or Readings 8 8
Difficult to Remove 7 7
Loose or Intermittent Connection 7 7
Mechanical Problem 6 6
No Display/Image 6 6
Defective Device 6 6
Failure to Advance 6 6
Failure to Disconnect 6 6
Material Twisted/Bent 6 6
Noise, Audible 5 5
Positioning Problem 5 5
Device Fell 5 5
High Readings 5 5
Device Slipped 5 5
Invalid Sensing 5 5
Failure to Fire 4 4
Migration or Expulsion of Device 4 4
Separation Problem 4 4
Material Integrity Problem 4 4
Physical Resistance/Sticking 4 4
Premature Separation 4 4
Output Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Data Back-Up Problem 4 4
Device Operational Issue 4 4
Material Distortion 3 3
Device Dislodged or Dislocated 3 3
Power Problem 3 3
Unexpected Shutdown 3 3
Low pH 3 3
Image Resolution Poor 3 3
Difficult to Insert 3 3
Device Alarm System 3 3
Date/Time-Related Software Problem 3 3
Defective Component 3 3
Failure to Sense 3 3
Use of Device Problem 3 3
Improper or Incorrect Procedure or Method 2 2
Suction Problem 2 2
Misfire 2 2
Patient-Device Incompatibility 2 2
Blocked Connection 2 2
Chemical Problem 2 2
Intermittent Continuity 2 2
Component Falling 2 2
Premature Activation 2 2
Off-Label Use 2 2
Firing Problem 2 2
Patient Device Interaction Problem 2 2
Migration 2 2
Wireless Communication Problem 1 1
Programming Issue 1 1
Protective Measures Problem 1 1
Unintended Movement 1 1
Human-Device Interface Problem 1 1
Improper Device Output 1 1
Compatibility Problem 1 1
Material Deformation 1 1
Mechanics Altered 1 1
Device Sensing Problem 1 1
Device-Device Incompatibility 1 1
Difficult to Open or Close 1 1
Complete Loss of Power 1 1
Inaccurate Information 1 1
Key or Button Unresponsive/not Working 1 1
Unable to Obtain Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 2386 2386
No Known Impact Or Consequence To Patient 1580 1580
No Clinical Signs, Symptoms or Conditions 693 693
Foreign Body In Patient 287 287
Airway Obstruction 268 268
No Information 96 96
Aspiration/Inhalation 66 66
Chest Pain 63 63
Insufficient Information 57 57
Radiation Exposure, Unintended 56 56
Pain 54 54
No Code Available 49 49
Injury 45 45
No Patient Involvement 38 38
Laceration(s) of Esophagus 27 27
Unintended Radiation Exposure 23 23
Discomfort 19 19
Oversedation 17 17
Hemorrhage/Bleeding 17 17
Sedation 17 17
Tissue Damage 11 11
Cough 11 11
Dysphagia/ Odynophagia 9 9
Blood Loss 9 9
Vomiting 9 9
Failure of Implant 8 8
Sore Throat 8 8
Unspecified Tissue Injury 8 8
Ulcer 7 7
Nausea 5 5
Abdominal Pain 5 5
Inflammation 5 5
Dyspnea 5 5
Low Oxygen Saturation 4 4
Hypoxia 4 4
Perforation 4 4
Fever 4 4
Death 4 4
Laceration(s) 4 4
Reaction 3 3
Perforation of Esophagus 3 3
Ulceration 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Collapse 2 2
Foreign Body Sensation in Eye 2 2
Pyrosis/Heartburn 2 2
Device Embedded In Tissue or Plaque 2 2
Asthma 2 2
Dizziness 2 2
Choking 2 2
Swelling 2 2
Bowel Perforation 2 2
Cramp(s) 1 1
Nasal Obstruction 1 1
Chills 1 1
Abrasion 1 1
Cyanosis 1 1
Malaise 1 1
Burn(s) 1 1
Internal Organ Perforation 1 1
Not Applicable 1 1
Bradycardia 1 1
Constipation 1 1
Respiratory Distress 1 1
Tissue Breakdown 1 1
Stenosis 1 1
Burning Sensation 1 1
Itching Sensation 1 1
Diarrhea 1 1
Unspecified Infection 1 1
Cardiogenic Shock 1 1
Sweating 1 1
Rash 1 1
Hernia 1 1
Arteriosclerosis 1 1
Vessel Or Plaque, Device Embedded In 1 1
Numbness 1 1
Neck Pain 1 1
Missing Value Reason 1 1
Respiratory Tract Infection 1 1
Swelling/ Edema 1 1
Respiratory Insufficiency 1 1
Apnea 1 1
Tingling 1 1
Loss of Vision 1 1
Overdose 1 1
Low Blood Pressure/ Hypotension 1 1
Awareness during Anaesthesia 1 1
Irritation 1 1
Hematoma 1 1
Hypersensitivity/Allergic reaction 1 1
Erosion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Covidien LLC II May-06-2016
2 Covidien Llc II Apr-01-2021
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