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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, gastrointestinal motility (electrical)
Product CodeFFX
Regulation Number 876.1725
Device Class 2


Premarket Reviews
ManufacturerDecision
ANX ROBOTICA CORP.
  SUBSTANTIALLY EQUIVALENT 2
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 2
CROSPON LTD
  SUBSTANTIALLY EQUIVALENT 1
CROSPON LTD.
  SUBSTANTIALLY EQUIVALENT 2
CROSPON, LTD.
  SUBSTANTIALLY EQUIVALENT 4
DIVERSATEK HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
E-CATH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GIVEN IMAGING LTD.
  SUBSTANTIALLY EQUIVALENT 1
KONSYL PHARMACEUTICALS
  SUBSTANTIALLY EQUIVALENT 1
LABORIE MEDICAL TECHNOLOGIES CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL MEASUREMENT SYSTEMS,B.V.
  SUBSTANTIALLY EQUIVALENT 1
MEDIFACTIA AB
  SUBSTANTIALLY EQUIVALENT 2
MUI SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 3
SIERRA SCIENTIFIC INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 4 4
2015 10 10
2016 15 15
2017 10 10
2018 17 17
2019 27 27
2020 20 20
2021 26 26
2022 31 31
2023 51 51
2024 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Remove 101 101
Material Integrity Problem 18 18
Adverse Event Without Identified Device or Use Problem 16 16
Material Deformation 12 12
Insufficient Information 11 11
Therapeutic or Diagnostic Output Failure 9 9
Device Displays Incorrect Message 7 7
Failure to Calibrate 6 6
Failure of Device to Self-Test 6 6
Device Operates Differently Than Expected 5 5
Patient-Device Incompatibility 5 5
Device Damaged Prior to Use 5 5
Break 5 5
Detachment of Device or Device Component 4 4
Pressure Problem 4 4
Material Split, Cut or Torn 3 3
Gradient Increase 3 3
Detachment Of Device Component 3 3
Inadequacy of Device Shape and/or Size 3 3
Poor Quality Image 3 3
Labelling, Instructions for Use or Training Problem 3 3
Product Quality Problem 3 3
Material Fragmentation 2 2
Smoking 2 2
Sticking 2 2
Defective Component 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Material Separation 2 2
Excess Flow or Over-Infusion 2 2
Entrapment of Device 2 2
Premature Separation 2 2
Noise, Audible 2 2
Defective Device 2 2
Device Sensing Problem 2 2
Application Program Problem 2 2
Calibration Problem 2 2
Contamination /Decontamination Problem 1 1
Computer Operating System Problem 1 1
Loss of Data 1 1
Activation, Positioning or Separation Problem 1 1
Failure to Advance 1 1
Split 1 1
Physical Resistance 1 1
Date/Time-Related Software Problem 1 1
Patient Device Interaction Problem 1 1
Data Problem 1 1
Air/Gas in Device 1 1
Physical Resistance/Sticking 1 1
Unintended Electrical Shock 1 1
Protective Measures Problem 1 1
Torn Material 1 1
No Apparent Adverse Event 1 1
Impedance Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Output Problem 1 1
Problem with Removal of Enzymatic Cleaner 1 1
Fluid/Blood Leak 1 1
Burst Container or Vessel 1 1
Device Reprocessing Problem 1 1
Device Alarm System 1 1
Loss of or Failure to Bond 1 1
Component Falling 1 1
Contamination 1 1
Intermittent Continuity 1 1
Crack 1 1
Deflation Problem 1 1
No Display/Image 1 1
Display or Visual Feedback Problem 1 1
Device Inoperable 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Inadequate Instructions for Healthcare Professional 1 1
Failure to Power Up 1 1
Device Difficult to Setup or Prepare 1 1
Device Difficult to Program or Calibrate 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 62 62
No Known Impact Or Consequence To Patient 25 25
Insufficient Information 23 23
Foreign Body In Patient 16 16
Hemorrhage/Bleeding 16 16
No Consequences Or Impact To Patient 12 12
No Code Available 11 11
Pain 11 11
Discomfort 10 10
Blood Loss 9 9
Injury 6 6
Unspecified Tissue Injury 6 6
No Information 5 5
Epistaxis 5 5
Sedation 5 5
Tissue Damage 5 5
Airway Obstruction 5 5
Obstruction/Occlusion 4 4
Nasal Obstruction 4 4
Sore Throat 4 4
No Patient Involvement 4 4
Radiation Exposure, Unintended 3 3
Device Embedded In Tissue or Plaque 3 3
Perforation of Esophagus 3 3
Laceration(s) 3 3
Pneumothorax 3 3
Inflammation 2 2
Pulmonary Emphysema 2 2
Laceration(s) of Esophagus 2 2
Convulsion/Seizure 2 2
Cough 1 1
Patient Problem/Medical Problem 1 1
Electric Shock 1 1
Hematoma 1 1
Failure of Implant 1 1
Unspecified Infection 1 1
Exposure to Body Fluids 1 1
Bradycardia 1 1
Dyspnea 1 1
Paralysis 1 1
Rash 1 1
Scar Tissue 1 1
Swelling 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Diversatek Healthcare III Sep-07-2023
2 Sandhill Scientific, Inc II May-07-2012
3 Sierra Scientific Instruments Inc II Oct-28-2011
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