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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 CodeNSI
Regulation Number 876.1300
Device Class 2

MDR Year MDR Reports MDR Events
2019 3 3
2020 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Entrapment of Device 2 2
Device Markings/Labelling Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Abdominal Pain 1 1
Vomiting 1 1
Bowel Perforation 1 1
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1
Radiation Exposure, Unintended 1 1
Insufficient Information 1 1

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