TPLC - Total Product Life Cycle

• Device: system, imaging, esophageal, wireless, capsule
• Definition: THE CAPSULE IS A DISPOSABLE, INGESTIBLE CAPSULE DESIGNED TO ACQUIRE VIDEO IMAGES OF THE ESOPHAGUS. THE CAPSULE TRANSMITS THE ACQUIRED IMAGES VIA RF COMMUNICATION CHANNEL TO A DATA RECORDER LOCATED OUTSIDE THE BODY. THE DIAGNOSTIC IMAGING SYSTEM IS INTENDED FOR VISUALIZATION OF THE ESOPHAGUS RATHER THAN THE SMALL BOWEL.
• Product Code: NSI
• Regulation Number: 876.1300
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
GIVEN IMAGING LTD.
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2014	2	2
2015	1	1
2016	3	3
2017	1	1
2018	15	15
2019	3	3
2020	1	1
2023	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Entrapment of Device	8	8
Adverse Event Without Identified Device or Use Problem	4	4
Data Problem	3	3
Premature Discharge of Battery	2	2
Device Operates Differently Than Expected	2	2
Material Fragmentation	2	2
Defective Component	2	2
Capturing Problem	1	1
Loss of Data	1	1
Device Markings/Labelling Problem	1	1
No Device Output	1	1
Failure to Transmit Record	1	1
Inaccurate Synchronization	1	1
Human-Device Interface Problem	1	1
Failure to Capture	1	1
Therapeutic or Diagnostic Output Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	8	8
Abdominal Pain	7	7
Radiation Exposure, Unintended	6	6
No Information	3	3
Sore Throat	2	2
Nausea	2	2
Pain	2	2
Vomiting	2	2
Burning Sensation	1	1
No Consequences Or Impact To Patient	1	1
Discomfort	1	1
Chest Pain	1	1
Diarrhea	1	1
Headache	1	1
Bowel Perforation	1	1
Foreign Body In Patient	1	1
Cancer	1	1
Insufficient Information	1	1