inforMED
InjuryNSI

PILLCAM

Received Sep 18, 2018 · Event occurred Aug 24, 2018

Report 9710107-2018-00951 · MDR key 7887381

Device

Generic name

System, Imaging, Esophageal, Wireless, Capsule

Model number

FGS-0109

Catalog number

FGS-0109

Lot number

39952

Product problems

  • Entrapment of Device
  • Entrapment of Device

Patient

89 YR

  • Radiation Exposure, Unintended
  • Cancer
  • Radiation Exposure, Unintended
  • Cancer

Narrative

Additional Manufacturer Narrative

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, THE PATENCY CAPSULE WAS STILL IN THE ASCENDING COLON OF THE PATIENT AS CONFIRMED BY THE COMPUTED TOMOGRAPHY AND THREE X-RAY'S. THE PATIENT WAS THEN ADMITTED FOR GASTROINTESTINAL BLEEDING AND HAS A HISTORY OF COLON CANCER. THE MEDICAL ADVISOR EXPLAINED TO THE CUSTOMER THAT THE PATENCY CAPSULE WILL DISSOLVE AND WILL BE EXPULSED NATURALLY, AND THAT IT WILL BE DEFINED AS A RETAINED CAPSULE AFTER FIFTEEN DAYS. THE PATIENT HAD A HISTORY OF PRIOR GASTROINTESTINAL BLEEDING, MELENA, AND COLON CANCER. THE PATIENT IS STILL HOSPITALIZED, ADDITIONAL DIAGNOSIS PNEUMONITIS AND WILL CONTINUE TO BE MONITORED AND THE PHYSICIAN WILL DECIDE THE BEST ACTION. THE X-RAY SHOWED SOME COLONIC DIVERTICULAR PRESENT AND THE CAPSULE WAS SEEN.