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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
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 3
GIVEN IMAGING LTD.
  SUBSTANTIALLY EQUIVALENT 9
GIVEN IMAGING LTD. (MEDTRONIC)
  SUBSTANTIALLY EQUIVALENT 2
INTROMEDIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 5
INTROMEDIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 5
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES ENDOSCOPY GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 12 12
2015 30 30
2016 57 57
2017 55 55
2018 50 50
2019 56 56
2020 31 31
2021 41 41
2022 63 63
2023 34 34
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Entrapment of Device 151 151
Adverse Event Without Identified Device or Use Problem 65 65
Output Problem 25 25
Insufficient Information 23 23
Device Operates Differently Than Expected 22 22
Unintended Application Program Shut Down 16 16
Human-Device Interface Problem 13 13
Positioning Problem 13 13
Communication or Transmission Problem 12 12
Failure to Transmit Record 9 9
Difficult to Remove 8 8
Loss of Power 8 8
Detachment of Device or Device Component 8 8
Patient-Device Incompatibility 7 7
Appropriate Term/Code Not Available 7 7
Data Problem 7 7
No Display/Image 6 6
Defective Device 5 5
Inadequacy of Device Shape and/or Size 5 5
Break 5 5
Activation, Positioning or Separation Problem 5 5
Material Fragmentation 4 4
Device Displays Incorrect Message 4 4
Failure to Advance 3 3
Loss of Data 3 3
Therapeutic or Diagnostic Output Failure 3 3
Activation Problem 3 3
Material Protrusion/Extrusion 2 2
Mechanical Jam 2 2
Protective Measures Problem 2 2
Device Handling Problem 2 2
Patient Device Interaction Problem 2 2
Computer Operating System Problem 2 2
Connection Problem 2 2
Failure to Fire 2 2
Device Or Device Fragments Location Unknown 2 2
Device Inoperable 2 2
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Signal Artifact/Noise 2 2
Positioning Failure 2 2
Material Disintegration 2 2
Premature Discharge of Battery 1 1
Detachment Of Device Component 1 1
Computer Software Problem 1 1
Crack 1 1
Deflation Problem 1 1
Material Separation 1 1
Failure to Read Input Signal 1 1
Image Display Error/Artifact 1 1
Mechanical Problem 1 1
Migration or Expulsion of Device 1 1
Poor Quality Image 1 1
No Device Output 1 1
Component Missing 1 1
Out-Of-Box Failure 1 1
Device Contamination with Body Fluid 1 1
Device Slipped 1 1
Sticking 1 1
Device Stops Intermittently 1 1
Unexpected Therapeutic Results 1 1
Sparking 1 1
Failure To Adhere Or Bond 1 1
Malposition of Device 1 1
Aspiration Issue 1 1
Battery Problem 1 1
Device Markings/Labelling Problem 1 1
Material Integrity Problem 1 1
Device Operational Issue 1 1
Difficult to Advance 1 1
Device Dislodged or Dislocated 1 1
Migration 1 1
Firing Problem 1 1
Physical Resistance/Sticking 1 1
Missing Test Results 1 1
Activation Failure 1 1
Misassembly by Users 1 1
No Apparent Adverse Event 1 1
Failure to Clean Adequately 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 104 104
No Known Impact Or Consequence To Patient 82 82
Radiation Exposure, Unintended 57 57
No Clinical Signs, Symptoms or Conditions 40 40
No Consequences Or Impact To Patient 28 28
Obstruction/Occlusion 27 27
Abdominal Pain 26 26
No Code Available 24 24
No Information 20 20
Unintended Radiation Exposure 18 18
Vomiting 15 15
Discomfort 12 12
Insufficient Information 12 12
Aspiration/Inhalation 11 11
Pain 9 9
Death 8 8
Stenosis 8 8
Injury 8 8
Device Embedded In Tissue or Plaque 7 7
Nausea 6 6
Inflammation 4 4
Perforation 4 4
Diarrhea 4 4
Unspecified Gastrointestinal Problem 4 4
No Patient Involvement 3 3
Weight Changes 3 3
Burning Sensation 3 3
Low Blood Pressure/ Hypotension 3 3
Hypersensitivity/Allergic reaction 2 2
Unspecified Infection 2 2
Ischemia 2 2
Rash 2 2
Sepsis 2 2
Tissue Damage 2 2
Dyspnea 2 2
Foreign Body Reaction 2 2
Low Oxygen Saturation 2 2
Bowel Perforation 2 2
Tissue Breakdown 2 2
Patient Problem/Medical Problem 2 2
Peritonitis 2 2
Cough 2 2
Salivary Hypersecretion 1 1
Syncope/Fainting 1 1
Blister 1 1
Unspecified Tissue Injury 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Abdominal Cramps 1 1
Caustic/Chemical Burns 1 1
Abdominal Distention 1 1
Exit Block 1 1
Laceration(s) of Esophagus 1 1
Hernia 1 1
Ulcer 1 1
Complaint, Ill-Defined 1 1
Pyrosis/Heartburn 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Embolism 1 1
Erythema 1 1
Fever 1 1
Fistula 1 1
Cardiac Arrest 1 1
Infarction, Cerebral 1 1
Chest Pain 1 1
Abrasion 1 1
Abscess 1 1
Airway Obstruction 1 1
Anemia 1 1
Transient Ischemic Attack 1 1
Ventricular Tachycardia 1 1
Septic Shock 1 1
Seizures 1 1
Pneumonia 1 1
Laceration(s) 1 1
Undesired Nerve Stimulation 1 1
Hypoxia 1 1
Failure of Implant 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
4 Given Imaging Ltd. II Mar-23-2011
5 IntroMedic Co., Ltd. II May-03-2018
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