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
ANX ROBOTICA CORP
	SUBSTANTIALLY EQUIVALENT	1
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	80	80
Material Integrity Problem	18	18
Adverse Event Without Identified Device or Use Problem	11	11
Insufficient Information	10	10
Material Deformation	10	10
Failure of Device to Self-Test	8	8
Therapeutic or Diagnostic Output Failure	8	8
Failure to Calibrate	5	5
Pressure Problem	4	4
Break	4	4
Poor Quality Image	4	4
Gradient Increase	3	3
Material Split, Cut or Torn	3	3
Device Displays Incorrect Message	3	3
Smoking	3	3
Defective Device	3	3
Incorrect, Inadequate or Imprecise Result or Readings	3	3
Device Sensing Problem	3	3
Detachment of Device or Device Component	3	3
Inadequacy of Device Shape and/or Size	3	3
Device Difficult to Program or Calibrate	3	3
Fluid/Blood Leak	2	2
Activation, Positioning or Separation Problem	2	2
Premature Separation	2	2
No Apparent Adverse Event	2	2
Product Quality Problem	2	2
Excess Flow or Over-Infusion	2	2
Inflation Problem	2	2
Improper or Incorrect Procedure or Method	1	1
Display or Visual Feedback Problem	1	1
Failure to Deflate	1	1
Intermittent Continuity	1	1
Protective Measures Problem	1	1
Activation Failure	1	1
Material Separation	1	1
Incorrect Measurement	1	1
Data Problem	1	1
Computer Operating System Problem	1	1
Calibration Problem	1	1
Material Rupture	1	1
Thermal Decomposition of Device	1	1
Use of Device Problem	1	1
Device Difficult to Setup or Prepare	1	1
Failure to Power Up	1	1
Impedance Problem	1	1
Difficult to Insert	1	1
Air/Gas in Device	1	1
Patient Device Interaction Problem	1	1
Deflation Problem	1	1
Measurement System Incompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	111	111
Insufficient Information	33	33
Hemorrhage/Bleeding	17	17
Pain	10	10
Foreign Body In Patient	9	9
Airway Obstruction	7	7
Unspecified Tissue Injury	6	6
Epistaxis	5	5
Injury	5	5
Discomfort	5	5
Obstruction/Occlusion	4	4
Nasal Obstruction	4	4
Tissue Damage	4	4
Sore Throat	4	4
No Consequences Or Impact To Patient	4	4
Sedation	3	3
Pneumothorax	2	2
Blood Loss	2	2
Laceration(s)	2	2
Cough	2	2
Convulsion/Seizure	2	2
Patient Problem/Medical Problem	1	1
Unspecified Infection	1	1
Electric Shock	1	1
No Code Available	1	1
Failure of Implant	1	1
No Information	1	1
Perforation of Esophagus	1	1
Inflammation	1	1
Hematoma	1	1
Perforation	1	1
Laceration(s) of Esophagus	1	1
No Known Impact Or Consequence To Patient	1	1
No Patient Involvement	1	1
Vomiting	1	1
Scar Tissue	1	1
Dyspnea	1	1
Pneumonia	1	1
Distress	1	1