TPLC - Total Product Life Cycle

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Device	system, gastrointestinal motility (electrical)
Regulation Description	Gastrointestinal motility monitoring system.
Product Code	FFX
Regulation Number	876.1725
Device Class	2

Premarket Reviews
Manufacturer	Decision
COVIDIEN, LLC
	SUBSTANTIALLY EQUIVALENT	2
LABORIE MEDICAL TECHNOLOGIES, CORP.
	SUBSTANTIALLY EQUIVALENT	1
MEDIFACTIA AB
	SUBSTANTIALLY EQUIVALENT	1
MEDSPIRA, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Difficult to Remove	69	69
Manufacturing, Packaging or Shipping Problem	45	45
Insufficient Information	15	15
Material Integrity Problem	14	14
Adverse Event Without Identified Device or Use Problem	11	11
Failure of Device to Self-Test	10	10
Therapeutic or Diagnostic Output Failure	10	10
Material Deformation	7	7
Decrease in Pressure	7	7
Contamination /Decontamination Problem	7	7
Application Program Freezes, Becomes Nonfunctional	6	6
Defective Device	6	6
Pressure Problem	5	5
Device Sensing Problem	5	5
Break	4	4
Failure to Calibrate	4	4
Poor Quality Image	4	4
Device Difficult to Program or Calibrate	4	4
Gradient Increase	3	3
Fluid/Blood Leak	3	3
Device Displays Incorrect Message	3	3
No Apparent Adverse Event	3	3
Detachment of Device or Device Component	3	3
Inadequacy of Device Shape and/or Size	3	3
Inflation Problem	3	3
Incorrect, Inadequate or Imprecise Result or Readings	3	3
Smoking	3	3
Material Split, Cut or Torn	3	3
Difficult to Insert	2	2
Excess Flow or Over-Infusion	2	2
Material Puncture/Hole	2	2
Product Quality Problem	2	2
Premature Separation	2	2
Activation, Positioning or Separation Problem	2	2
Patient Device Interaction Problem	1	1
Air/Gas in Device	1	1
Impedance Problem	1	1
Failure to Power Up	1	1
Device Difficult to Setup or Prepare	1	1
Use of Device Problem	1	1
Thermal Decomposition of Device	1	1
Measurement System Incompatibility	1	1
Defective Component	1	1
Failure to Sense	1	1
Material Rupture	1	1
Calibration Problem	1	1
Data Problem	1	1
Incorrect Measurement	1	1
Material Separation	1	1
Material Disintegration	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	185	185
Insufficient Information	33	33
Hemorrhage/Bleeding	17	17
Pain	10	10
Foreign Body In Patient	8	8
Convulsion/Seizure	8	8
Airway Obstruction	7	7
Obstruction/Occlusion	4	4
Discomfort	3	3
Nasal Obstruction	3	3
Sore Throat	3	3
Pneumothorax	2	2
Epistaxis	2	2
Laceration(s)	2	2
Cough	2	2
Unspecified Infection	1	1
Electric Shock	1	1
Failure of Implant	1	1
Perforation of Esophagus	1	1
Hematoma	1	1
Inflammation	1	1
Perforation	1	1
Laceration(s) of Esophagus	1	1
Vomiting	1	1
Dyspnea	1	1
Scar Tissue	1	1
Pneumonia	1	1
Unspecified Tissue Injury	1	1
Distress	1	1