inforMED
InjuryNSI

PILLCAM® PATENCY CAPSULE

Received Oct 23, 2017 · Event occurred Aug 18, 2017

Report 9710107-2017-05576 · MDR key 6968421

Device

Generic name

System, Imaging, Esophageal, Wireless, Capsule

Model number

FGS-0109

Catalog number

FGS-0109

Lot number

35938

Product problems

  • Entrapment of Device
  • Entrapment of Device

Patient

51 YR

  • Radiation Exposure, Unintended
  • Radiation Exposure, Unintended

Narrative

Description of Event or Problem

ACCORDING TO THE REPORTER, THE DEVICE HAD RETAINED PATENCY CAPSULE. THE RFID TAG HAD BEEN RETAINED IN THE PATIENT FOR ABOUT 2 WEEKS. CUSTOMER WAS REQUESTING TO BE CONTACTED BY THE MEDICAL ADVISORS. NO PATIENT HARM REPORTED.