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	86	86
Entrapment of Device	78	78
Output Problem	24	24
Insufficient Information	18	18
Human-Device Interface Problem	10	10
Detachment of Device or Device Component	7	7
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
No Apparent Adverse Event	3	3
Therapeutic or Diagnostic Output Failure	3	3
Failure to Transmit Record	3	3
Activation Problem	3	3
Patient-Device Incompatibility	2	2
Positioning Problem	2	2
Patient Device Interaction Problem	2	2
Communication or Transmission Problem	2	2
Data Problem	2	2
Device Handling Problem	2	2
Failure to Fire	2	2
Material Protrusion/Extrusion	2	2
Image Display Error/Artifact	1	1
Defective Device	1	1
Crack	1	1
Failure to Clean Adequately	1	1
Deflation Problem	1	1
Optical Distortion	1	1
No Display/Image	1	1
Separation Problem	1	1
Computer Operating System Problem	1	1
Expulsion	1	1
Activation, Positioning or Separation Problem	1	1
Failure to Read Input Signal	1	1
Activation Failure	1	1
Device Dislodged or Dislocated	1	1
Unexpected Therapeutic Results	1	1
Signal Artifact/Noise	1	1
Premature Discharge of Battery	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	141	141
No Clinical Signs, Symptoms or Conditions	62	62
Unintended Radiation Exposure	19	19
Abdominal Pain	14	14
Insufficient Information	14	14
Obstruction/Occlusion	12	12
Radiation Exposure, Unintended	8	8
No Consequences Or Impact To Patient	5	5
Aspiration/Inhalation	5	5
No Known Impact Or Consequence To Patient	5	5
Discomfort	5	5
Nausea	4	4
Unspecified Gastrointestinal Problem	4	4
Vomiting	4	4
Pain	4	4
No Information	3	3
Inflammation	3	3
Cough	3	3
Injury	3	3
Weight Changes	2	2
Tissue Breakdown	2	2
Death	2	2
Hypersensitivity/Allergic reaction	2	2
Low Oxygen Saturation	2	2
Failure of Implant	2	2
Foreign Body Reaction	2	2
Burning Sensation	2	2
Chest Pain	2	2
Diarrhea	2	2
Dyspnea	2	2
Low Blood Pressure/ Hypotension	1	1
Airway Obstruction	1	1
Caustic/Chemical Burns	1	1
Ulcer	1	1
Unspecified Tissue Injury	1	1
Salivary Hypersecretion	1	1
Stenosis	1	1
Undesired Nerve Stimulation	1	1
Laceration(s)	1	1
Erythema	1	1
Rash	1	1
Blister	1	1
Laceration(s) of Esophagus	1	1
Pyrosis/Heartburn	1	1
Anemia	1	1
Perforation	1	1
Bowel Perforation	1	1
No Code Available	1	1
Sepsis	1	1
Complaint, Ill-Defined	1	1