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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device colon capsule imaging system
Definition visualization of the colon for the detection of polyps
Product CodePGD
Regulation Number 876.1330
Device Class 2


Premarket Reviews
ManufacturerDecision
GIVEN IMAGING LTD.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2016 1 1
2017 1 1
2018 1 1
2019 1 1
2020 1 1
2021 3 3
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Insufficient Information 1 1
Unintended Application Program Shut Down 1 1
Human-Device Interface Problem 1 1
Entrapment of Device 1 1
Component Missing 1 1
Incorrect Or Inadequate Test Results 1 1
Patient-Device Incompatibility 1 1
Communication or Transmission Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 2 2
No Known Impact Or Consequence To Patient 2 2
No Code Available 2 2
Unintended Radiation Exposure 2 2
Insufficient Information 1 1
Constipation 1 1
Paresthesia 1 1
Unspecified Eye / Vision Problem 1 1
Regurgitation 1 1
Arthralgia 1 1
Numbness 1 1
Irritability 1 1
Choking 1 1
Confusion/ Disorientation 1 1
Lethargy 1 1
Foreign Body In Patient 1 1
Abdominal Pain 1 1
Dehydration 1 1
Diarrhea 1 1
Dyspnea 1 1
Fatigue 1 1
Fever 1 1
Low Blood Pressure/ Hypotension 1 1
Inflammation 1 1
Nausea 1 1
Pain 1 1
Vomiting 1 1
Dizziness 1 1

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