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
Manufacturer
Given Imaging Ltd., YoqneamModel number
FGS-0109Catalog 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.