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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, imaging, gastrointestinal, wireless, capsule
Regulation Description Ingestible telemetric gastrointestinal capsule imaging system.
Product CodeNEZ
Regulation Number 876.1300
Device Class 2


Premarket Reviews
ManufacturerDecision
ANKON TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANX ROBOTICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CAPSOVISION, INC.
  SUBSTANTIALLY EQUIVALENT 2
GIVEN IMAGING LTD. (D.B.A. MEDTRONIC)
  SUBSTANTIALLY EQUIVALENT 1
GIVEN IMAGING LTD. (MEDTRONIC)
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 41 41
2022 63 63
2023 34 34
2024 102 102
2025 69 69

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 107 107
Entrapment of Device 74 74
Output Problem 24 24
Insufficient Information 20 20
Human-Device Interface Problem 13 13
Detachment of Device or Device Component 8 8
Break 7 7
Failure to Transmit Record 7 7
Unintended Application Program Shut Down 6 6
Material Fragmentation 6 6
Inadequacy of Device Shape and/or Size 5 5
Difficult to Remove 4 4
Separation Problem 3 3
Activation Problem 3 3
Smoking 3 3
No Apparent Adverse Event 3 3
Patient Device Interaction Problem 3 3
Failure to Fire 3 3
Activation, Positioning or Separation Problem 2 2
Communication or Transmission Problem 2 2
Failure to Eject 2 2
Device Dislodged or Dislocated 2 2
Failure to Advance 2 2
Therapeutic or Diagnostic Output Failure 2 2
Data Problem 2 2
Loss of or Failure to Bond 1 1
Improper or Incorrect Procedure or Method 1 1
Loss of Power 1 1
Display or Visual Feedback Problem 1 1
Unexpected Therapeutic Results 1 1
Activation Failure 1 1
Material Protrusion/Extrusion 1 1
Device Handling Problem 1 1
Computer Operating System Problem 1 1
Ejection Problem 1 1
Optical Distortion 1 1
Deflation Problem 1 1
Failure to Clean Adequately 1 1
Positioning Problem 1 1
Defective Device 1 1
Patient-Device Incompatibility 1 1
Image Display Error/Artifact 1 1
Crack 1 1
Off-Label Use 1 1
No Display/Image 1 1
Expulsion 1 1
Signal Artifact/Noise 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 163 163
No Clinical Signs, Symptoms or Conditions 82 82
Insufficient Information 19 19
Unintended Radiation Exposure 17 17
Obstruction/Occlusion 11 11
Abdominal Pain 10 10
Discomfort 6 6
Pain 5 5
Nausea 4 4
Unspecified Gastrointestinal Problem 4 4
Aspiration/Inhalation 4 4
Hypersensitivity/Allergic reaction 3 3
Cough 3 3
Low Oxygen Saturation 2 2
Airway Obstruction 2 2
Choking 2 2
Chest Pain 2 2
Burning Sensation 2 2
Foreign Body Reaction 2 2
Inflammation 2 2
Bowel Perforation 2 2
Rash 1 1
Blister 1 1
Laceration(s) of Esophagus 1 1
Pyrosis/Heartburn 1 1
Diarrhea 1 1
Erythema 1 1
Vomiting 1 1
Anemia 1 1
Dyspnea 1 1
Laceration(s) 1 1
Sepsis 1 1
Undesired Nerve Stimulation 1 1
Failure of Implant 1 1
Salivary Hypersecretion 1 1
Unspecified Tissue Injury 1 1
Ulcer 1 1
Caustic/Chemical Burns 1 1
Respiratory Insufficiency 1 1
Electric Shock 1 1
Low Blood Pressure/ Hypotension 1 1
Syncope/Fainting 1 1
Tissue Breakdown 1 1
Weight Changes 1 1

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