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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
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 1
CAPSOVISION, INC.
  SUBSTANTIALLY EQUIVALENT 1
GIVEN IMAGING LTD. (D.B.A. MEDTRONIC)
  SUBSTANTIALLY EQUIVALENT 1
GIVEN IMAGING LTD. (MEDTRONIC)
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 31 31
2021 41 41
2022 63 63
2023 34 34
2024 102 102
2025 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 83 83
Entrapment of Device 78 78
Output Problem 24 24
Insufficient Information 18 18
Human-Device Interface Problem 10 10
Break 7 7
Detachment of Device or Device Component 7 7
Inadequacy of Device Shape and/or Size 5 5
Unintended Application Program Shut Down 5 5
Material Fragmentation 5 5
Difficult to Remove 4 4
Failure to Transmit Record 3 3
Therapeutic or Diagnostic Output Failure 3 3
No Apparent Adverse Event 3 3
Activation Problem 3 3
Data Problem 2 2
Positioning Problem 2 2
Patient-Device Incompatibility 2 2
Failure to Fire 2 2
Device Handling Problem 2 2
Material Protrusion/Extrusion 2 2
Patient Device Interaction Problem 2 2
Communication or Transmission Problem 2 2
Device Dislodged or Dislocated 1 1
Unexpected Therapeutic Results 1 1
Optical Distortion 1 1
Computer Operating System Problem 1 1
Activation, Positioning or Separation Problem 1 1
Image Display Error/Artifact 1 1
Activation Failure 1 1
Loss of Power 1 1
Defective Device 1 1
Improper or Incorrect Procedure or Method 1 1
Premature Discharge of Battery 1 1
Expulsion 1 1
Separation Problem 1 1
Failure to Clean Adequately 1 1
No Display/Image 1 1
Failure to Read Input Signal 1 1
Deflation Problem 1 1
Crack 1 1
Signal Artifact/Noise 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 140 140
No Clinical Signs, Symptoms or Conditions 62 62
Unintended Radiation Exposure 19 19
Insufficient Information 14 14
Abdominal Pain 14 14
Obstruction/Occlusion 12 12
Radiation Exposure, Unintended 8 8
No Known Impact Or Consequence To Patient 5 5
Discomfort 5 5
No Consequences Or Impact To Patient 5 5
Aspiration/Inhalation 4 4
Vomiting 4 4
Unspecified Gastrointestinal Problem 4 4
Pain 4 4
Nausea 3 3
Injury 3 3
Inflammation 3 3
No Information 3 3
Failure of Implant 2 2
Hypersensitivity/Allergic reaction 2 2
Tissue Breakdown 2 2
Death 2 2
Cough 2 2
Dyspnea 2 2
Burning Sensation 2 2
Foreign Body Reaction 2 2
Diarrhea 2 2
Low Oxygen Saturation 2 2
Weight Changes 2 2
Rash 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Undesired Nerve Stimulation 1 1
Syncope/Fainting 1 1
Perforation 1 1
Low Blood Pressure/ Hypotension 1 1
Laceration(s) 1 1
No Code Available 1 1
Ulcer 1 1
Bowel Perforation 1 1
Chest Pain 1 1
Unspecified Tissue Injury 1 1
Sepsis 1 1
Stenosis 1 1
Caustic/Chemical Burns 1 1
Laceration(s) of Esophagus 1 1
Airway Obstruction 1 1
Complaint, Ill-Defined 1 1
Anemia 1 1
Blister 1 1
Erythema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Capso Vision, Inc. II Jul-08-2020
2 Capso Vision, Inc. II May-21-2020
3 Capso Vision, Inc. II Apr-30-2020
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