PILLCAM
Received Mar 14, 2019 · Event occurred Feb 18, 2019
Report 9710107-2019-00092 · MDR key 8422999
Device
Generic name
System, Imaging, Esophageal, Wireless, Capsule
Manufacturer
Given Imaging Ltd., YoqneamModel number
FGS-0110Catalog number
FGS-0110
Lot number
43713
Product problems
- Entrapment of Device
- Entrapment of Device
Patient
56 YR
- Radiation Exposure, Unintended
- Radiation Exposure, Unintended
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, THEY HAD A RETAINED CAPSULE. THE KUB (KIDNEY, URETER, BLADDER) X-RAY DONE SHOWED THAT THE PREVIOUSLY NOTED RECTANGULAR RADIODENSITY WAS NOW APPARENT AT THE LEFT ASPECT OF THE ABDOMEN/UPPER PELVIS, AT THE LEVEL OF THE PELVIC BRIM, PROBABLY IN THE DESCENDING COLON. IT WAS ASSUMED THAT THE PATIENT PASSED THE CAPSULE. THE PATIENT REPORTED DAILY BOWEL MOVEMENT WITH NO ABDOMINAL PAIN. THE LAST KNOWN PATIENT STATUS WAS DOING WELL.