TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Difficult to Remove	103	103
Material Integrity Problem	18	18
Adverse Event Without Identified Device or Use Problem	17	17
Material Deformation	12	12
Insufficient Information	11	11
Therapeutic or Diagnostic Output Failure	9	9
Device Displays Incorrect Message	7	7
Failure of Device to Self-Test	6	6
Failure to Calibrate	6	6
Device Operates Differently Than Expected	5	5
Patient-Device Incompatibility	5	5
Device Damaged Prior to Use	5	5
Break	5	5
Pressure Problem	4	4
Poor Quality Image	4	4
Product Quality Problem	4	4
Detachment of Device or Device Component	4	4
Detachment Of Device Component	3	3
Gradient Increase	3	3
Inadequacy of Device Shape and/or Size	3	3
Labelling, Instructions for Use or Training Problem	3	3
Defective Device	3	3
Material Split, Cut or Torn	3	3
Defective Component	2	2
Smoking	2	2
Material Separation	2	2
Device Sensing Problem	2	2
Device Difficult to Program or Calibrate	2	2
Sticking	2	2
Noise, Audible	2	2
Application Program Problem	2	2
Premature Separation	2	2
Calibration Problem	2	2
Entrapment of Device	2	2
Excess Flow or Over-Infusion	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Material Fragmentation	2	2
Improper or Incorrect Procedure or Method	1	1
Loss of Data	1	1
Display or Visual Feedback Problem	1	1
Device Inoperable	1	1
Intermittent Continuity	1	1
Device Reprocessing Problem	1	1
Failure to Advance	1	1
Protective Measures Problem	1	1
Date/Time-Related Software Problem	1	1
Computer Operating System Problem	1	1
Physical Resistance	1	1
Data Problem	1	1
Use of Device Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	72	72
Insufficient Information	28	28
No Known Impact Or Consequence To Patient	25	25
Hemorrhage/Bleeding	18	18
Foreign Body In Patient	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
Unspecified Tissue Injury	6	6
Injury	6	6
Airway Obstruction	5	5
No Information	5	5
Tissue Damage	5	5
Sedation	5	5
Epistaxis	5	5
Pneumothorax	4	4
Sore Throat	4	4
Nasal Obstruction	4	4
Obstruction/Occlusion	4	4
No Patient Involvement	4	4
Device Embedded In Tissue or Plaque	3	3
Laceration(s)	3	3
Perforation of Esophagus	3	3
Radiation Exposure, Unintended	3	3
Laceration(s) of Esophagus	2	2
Inflammation	2	2
Pulmonary Emphysema	2	2
Convulsion/Seizure	2	2
Exposure to Body Fluids	1	1
Swelling	1	1
Paralysis	1	1
Rash	1	1
Perforation	1	1
Scar Tissue	1	1
Dyspnea	1	1
Hematoma	1	1
Bradycardia	1	1
Pneumonia	1	1
Cough	1	1
Failure of Implant	1	1
Electric Shock	1	1
Unspecified Infection	1	1
Patient Problem/Medical Problem	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