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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
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
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 56 56
2020 31 31
2021 41 41
2022 63 63
2023 34 34
2024 76 76

Device Problems MDRs with this Device Problem Events in those MDRs
Entrapment of Device 104 104
Adverse Event Without Identified Device or Use Problem 80 80
Output Problem 24 24
Insufficient Information 17 17
Unintended Application Program Shut Down 12 12
Human-Device Interface Problem 11 11
Break 7 7
Detachment of Device or Device Component 6 6
Inadequacy of Device Shape and/or Size 5 5
Failure to Transmit Record 5 5
Activation, Positioning or Separation Problem 4 4
Activation Problem 4 4
Material Fragmentation 4 4
Loss of Power 3 3
Therapeutic or Diagnostic Output Failure 3 3
Data Problem 3 3
Difficult to Remove 3 3
Device Handling Problem 2 2
Defective Device 2 2
Patient Device Interaction Problem 2 2
Positioning Problem 2 2
Patient-Device Incompatibility 2 2
Communication or Transmission Problem 2 2
Failure to Fire 2 2
Signal Artifact/Noise 2 2
Material Protrusion/Extrusion 2 2
Use of Device Problem 1 1
Computer Operating System Problem 1 1
Deflation Problem 1 1
Failure to Clean Adequately 1 1
Image Display Error/Artifact 1 1
Poor Quality Image 1 1
No Display/Image 1 1
Crack 1 1
No Apparent Adverse Event 1 1
Activation Failure 1 1
Failure to Read Input Signal 1 1
Unexpected Therapeutic Results 1 1
Mechanical Jam 1 1
Improper or Incorrect Procedure or Method 1 1
Premature Discharge of Battery 1 1
Separation Problem 1 1
Loss of Data 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 134 134
No Clinical Signs, Symptoms or Conditions 49 49
Radiation Exposure, Unintended 30 30
Abdominal Pain 20 20
Unintended Radiation Exposure 18 18
No Known Impact Or Consequence To Patient 17 17
No Consequences Or Impact To Patient 13 13
Insufficient Information 13 13
Obstruction/Occlusion 11 11
Vomiting 8 8
Discomfort 6 6
Injury 6 6
No Information 6 6
Aspiration/Inhalation 6 6
Nausea 4 4
Unspecified Gastrointestinal Problem 4 4
Inflammation 4 4
Perforation 4 4
Pain 3 3
Diarrhea 3 3
Burning Sensation 3 3
No Code Available 3 3
Death 3 3
Foreign Body Reaction 2 2
Failure of Implant 2 2
Hypersensitivity/Allergic reaction 2 2
Dyspnea 2 2
Stenosis 2 2
Cough 2 2
Weight Changes 2 2
Low Blood Pressure/ Hypotension 2 2
Low Oxygen Saturation 2 2
Tissue Breakdown 2 2
Ischemia 1 1
Abdominal Distention 1 1
Pyrosis/Heartburn 1 1
Laceration(s) of Esophagus 1 1
Bowel Perforation 1 1
Blister 1 1
Peritonitis 1 1
Fever 1 1
Rash 1 1
Sepsis 1 1
Complaint, Ill-Defined 1 1
Chest Pain 1 1
Erythema 1 1
Hernia 1 1
Infarction, Cerebral 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Laceration(s) 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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