TPLC - Total Product Life Cycle

• Device: colon capsule imaging system
• Definition: visualization of the colon for the detection of polyps
• Product Code: PGD
• Regulation Number: 876.1330
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
GIVEN IMAGING LTD.
	GRANTED	1
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	1	1
2016	1	1
2017	1	1
2018	1	1
2019	1	1
2020	1	1
2021	3	3
2022	2	2
2024	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	2	2
Device Operates Differently Than Expected	2	2
Entrapment of Device	1	1
Communication or Transmission Problem	1	1
Patient-Device Incompatibility	1	1
Insufficient Information	1	1
Unintended Application Program Shut Down	1	1
Material Fragmentation	1	1
Component Missing	1	1
Incorrect Or Inadequate Test Results	1	1
Human-Device Interface Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Code Available	2	2
No Known Impact Or Consequence To Patient	2	2
No Consequences Or Impact To Patient	2	2
Unintended Radiation Exposure	2	2
Abdominal Pain	1	1
Arthralgia	1	1
Fatigue	1	1
Nausea	1	1
Dizziness	1	1
Inflammation	1	1
Confusion/ Disorientation	1	1
Paresthesia	1	1
Fever	1	1
Foreign Body In Patient	1	1
Diarrhea	1	1
Vomiting	1	1
Numbness	1	1
Unspecified Eye / Vision Problem	1	1
Insufficient Information	1	1
Dehydration	1	1
Dyspnea	1	1
Pain	1	1
Regurgitation	1	1
Choking	1	1
Anxiety	1	1
Irritability	1	1
Constipation	1	1
Low Blood Pressure/ Hypotension	1	1
Lethargy	1	1