TPLC - Total Product Life Cycle

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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	1
CAPSOVISION, INC.
	SUBSTANTIALLY EQUIVALENT	1
GIVEN IMAGING LTD. (D.B.A. MEDTRONIC)
	SUBSTANTIALLY EQUIVALENT	1
GIVEN IMAGING LTD. (MEDTRONIC)
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	98	98
Entrapment of Device	80	80
Output Problem	24	24
Insufficient Information	19	19
Human-Device Interface Problem	10	10
Detachment of Device or Device Component	9	9
Break	7	7
Inadequacy of Device Shape and/or Size	5	5
Material Fragmentation	5	5
Unintended Application Program Shut Down	5	5
Difficult to Remove	4	4
Failure to Transmit Record	4	4
No Apparent Adverse Event	3	3
Data Problem	3	3
Therapeutic or Diagnostic Output Failure	3	3
Activation Problem	3	3
Patient-Device Incompatibility	2	2
Smoking	2	2
Positioning Problem	2	2
Patient Device Interaction Problem	2	2
Communication or Transmission Problem	2	2
Device Handling Problem	2	2
Failure to Fire	2	2
Material Protrusion/Extrusion	2	2
Defective Device	1	1
Image Display Error/Artifact	1	1
Failure to Clean Adequately	1	1
Deflation Problem	1	1
Crack	1	1
Optical Distortion	1	1
No Display/Image	1	1
Computer Operating System Problem	1	1
Separation Problem	1	1
Expulsion	1	1
Activation, Positioning or Separation Problem	1	1
Failure to Read Input Signal	1	1
Activation Failure	1	1
Failure to Advance	1	1
Device Dislodged or Dislocated	1	1
Unexpected Therapeutic Results	1	1
Signal Artifact/Noise	1	1
Premature Discharge of Battery	1	1
Display or Visual Feedback Problem	1	1
Loss of Power	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Foreign Body In Patient	151	151
No Clinical Signs, Symptoms or Conditions	69	69
Unintended Radiation Exposure	19	19
Insufficient Information	16	16
Abdominal Pain	14	14
Obstruction/Occlusion	13	13
Radiation Exposure, Unintended	8	8
No Consequences Or Impact To Patient	5	5
Discomfort	5	5
Aspiration/Inhalation	5	5
No Known Impact Or Consequence To Patient	5	5
Pain	4	4
Nausea	4	4
Unspecified Gastrointestinal Problem	4	4
Vomiting	4	4
Cough	3	3
No Information	3	3
Inflammation	3	3
Injury	3	3
Low Oxygen Saturation	2	2
Tissue Breakdown	2	2
Dyspnea	2	2
Chest Pain	2	2
Diarrhea	2	2
Burning Sensation	2	2
Foreign Body Reaction	2	2
Bowel Perforation	2	2
Failure of Implant	2	2
Hypersensitivity/Allergic reaction	2	2
Death	2	2
Weight Changes	2	2
Anemia	1	1
Pyrosis/Heartburn	1	1
Rash	1	1
Blister	1	1
Laceration(s) of Esophagus	1	1
Perforation	1	1
Sepsis	1	1
Erythema	1	1
No Code Available	1	1
Laceration(s)	1	1
Choking	1	1
Stenosis	1	1
Unspecified Tissue Injury	1	1
Complaint, Ill-Defined	1	1
Undesired Nerve Stimulation	1	1
Salivary Hypersecretion	1	1
Caustic/Chemical Burns	1	1
Ulcer	1	1
Syncope/Fainting	1	1