TPLC - Total Product Life Cycle

show TPLC since

Device	system, imaging, gastrointestinal, wireless, capsule
Regulation Description	Ingestible telemetric gastrointestinal capsule imaging system.
Product Code	NEZ
Regulation Number	876.1300
Device Class	2

Premarket Reviews
Manufacturer	Decision
ANKON TECHNOLOGIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ANX ROBOTICA CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CAPSOVISION, INC.
	SUBSTANTIALLY EQUIVALENT	2
GIVEN IMAGING LTD. (D.B.A. MEDTRONIC)
	SUBSTANTIALLY EQUIVALENT	1
GIVEN IMAGING LTD. (MEDTRONIC)
	SUBSTANTIALLY EQUIVALENT	2
INTROMEDIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	108	108
Entrapment of Device	86	86
Output Problem	24	24
Insufficient Information	21	21
Human-Device Interface Problem	16	16
Failure to Transmit Record	9	9
Unintended Application Program Shut Down	8	8
Detachment of Device or Device Component	8	8
Break	7	7
Material Fragmentation	6	6
Inadequacy of Device Shape and/or Size	5	5
Difficult to Remove	4	4
Separation Problem	3	3
Activation Problem	3	3
Smoking	3	3
Therapeutic or Diagnostic Output Failure	3	3
Patient Device Interaction Problem	3	3
No Apparent Adverse Event	3	3
Failure to Fire	3	3
Activation, Positioning or Separation Problem	2	2
Communication or Transmission Problem	2	2
Failure to Eject	2	2
Overheating of Device	2	2
Defective Device	2	2
Device Dislodged or Dislocated	2	2
Failure to Advance	2	2
Data Problem	2	2
Loss of or Failure to Bond	1	1
Improper or Incorrect Procedure or Method	1	1
Loss of Power	1	1
Display or Visual Feedback Problem	1	1
Unexpected Therapeutic Results	1	1
Computer Software Problem	1	1
Activation Failure	1	1
Material Protrusion/Extrusion	1	1
Device Handling Problem	1	1
Computer Operating System Problem	1	1
Ejection Problem	1	1
Optical Distortion	1	1
Deflation Problem	1	1
Failure to Clean Adequately	1	1
Positioning Problem	1	1
Patient-Device Incompatibility	1	1
Image Display Error/Artifact	1	1
Crack	1	1
Off-Label Use	1	1
No Display/Image	1	1
Expulsion	1	1
Signal Artifact/Noise	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Foreign Body In Patient	176	176
No Clinical Signs, Symptoms or Conditions	90	90
Insufficient Information	20	20
Unintended Radiation Exposure	17	17
Obstruction/Occlusion	11	11
Abdominal Pain	10	10
Discomfort	7	7
Pain	5	5
Nausea	4	4
Choking	4	4
Unspecified Gastrointestinal Problem	4	4
Aspiration/Inhalation	4	4
Hypersensitivity/Allergic reaction	3	3
Cough	3	3
Low Oxygen Saturation	2	2
Airway Obstruction	2	2
Chest Pain	2	2
Burning Sensation	2	2
Foreign Body Reaction	2	2
Inflammation	2	2
Bowel Perforation	2	2
Rash	1	1
Blister	1	1
Laceration(s) of Esophagus	1	1
Pyrosis/Heartburn	1	1
Diarrhea	1	1
Erythema	1	1
Vomiting	1	1
Anemia	1	1
Dyspnea	1	1
Laceration(s)	1	1
Sepsis	1	1
Undesired Nerve Stimulation	1	1
Failure of Implant	1	1
Salivary Hypersecretion	1	1
Unspecified Tissue Injury	1	1
Ulcer	1	1
Caustic/Chemical Burns	1	1
Respiratory Insufficiency	1	1
Electric Shock	1	1
Low Blood Pressure/ Hypotension	1	1
Syncope/Fainting	1	1
Tissue Breakdown	1	1
Weight Changes	1	1