TPLC - Total Product Life Cycle

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Device	system, imaging, gastrointestinal, wireless, capsule
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
OLYMPUS MEDICAL SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Entrapment of Device	104	104
Adverse Event Without Identified Device or Use Problem	80	80
Output Problem	24	24
Insufficient Information	17	17
Unintended Application Program Shut Down	12	12
Human-Device Interface Problem	11	11
Break	7	7
Detachment of Device or Device Component	6	6
Inadequacy of Device Shape and/or Size	5	5
Failure to Transmit Record	5	5
Activation, Positioning or Separation Problem	4	4
Activation Problem	4	4
Material Fragmentation	4	4
Loss of Power	3	3
Data Problem	3	3
Difficult to Remove	3	3
Therapeutic or Diagnostic Output Failure	3	3
Positioning Problem	2	2
Defective Device	2	2
Patient-Device Incompatibility	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
Signal Artifact/Noise	2	2
Failure to Clean Adequately	1	1
Deflation Problem	1	1
Poor Quality Image	1	1
Image Display Error/Artifact	1	1
Use of Device Problem	1	1
Crack	1	1
Computer Operating System Problem	1	1
No Display/Image	1	1
Separation Problem	1	1
No Apparent Adverse Event	1	1
Activation Failure	1	1
Unexpected Therapeutic Results	1	1
Failure to Read Input Signal	1	1
Premature Discharge of Battery	1	1
Improper or Incorrect Procedure or Method	1	1
Loss of Data	1	1
Mechanical Jam	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Foreign Body In Patient	134	134
No Clinical Signs, Symptoms or Conditions	49	49
Radiation Exposure, Unintended	30	30
Abdominal Pain	20	20
Unintended Radiation Exposure	18	18
No Known Impact Or Consequence To Patient	17	17
No Consequences Or Impact To Patient	13	13
Insufficient Information	13	13
Obstruction/Occlusion	11	11
Vomiting	8	8
Discomfort	6	6
Injury	6	6
No Information	6	6
Aspiration/Inhalation	6	6
Nausea	4	4
Unspecified Gastrointestinal Problem	4	4
Inflammation	4	4
Perforation	4	4
Pain	3	3
Diarrhea	3	3
Burning Sensation	3	3
No Code Available	3	3
Death	3	3
Foreign Body Reaction	2	2
Failure of Implant	2	2
Hypersensitivity/Allergic reaction	2	2
Dyspnea	2	2
Stenosis	2	2
Cough	2	2
Weight Changes	2	2
Low Blood Pressure/ Hypotension	2	2
Low Oxygen Saturation	2	2
Tissue Breakdown	2	2
Ischemia	1	1
Abdominal Distention	1	1
Pyrosis/Heartburn	1	1
Laceration(s) of Esophagus	1	1
Bowel Perforation	1	1
Blister	1	1
Peritonitis	1	1
Fever	1	1
Rash	1	1
Sepsis	1	1
Complaint, Ill-Defined	1	1
Chest Pain	1	1
Erythema	1	1
Hernia	1	1
Infarction, Cerebral	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Laceration(s)	1	1