PILLCAM
Received Aug 12, 2021 · Event occurred Jul 15, 2021
Report 9710107-2021-00372 · MDR key 12315405
Device
Generic name
Colon Capsule Imaging System
Manufacturer
Given Imaging Ltd., YoqneamModel number
FGS-0517Catalog number
FGS-0517
Product problems
- Entrapment of Device
- Entrapment of Device
Patient
Not reported
- Unintended Radiation Exposure
- Unintended Radiation Exposure
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 PATIENT WAS ADMITTED INTO EMERGENCY WITH CAPSULE RETENTION AND WAS EXPERIENCING SYMPTOMS OF NAUSEA AND ABDOMINAL PAIN. THE RETENTION WAS IN THE SMALL BOWEL. THE SMALL BOWEL OBSTRUCTION WAS POSSIBLY COMPLICATED BY PERFORATION. THE PATIENT HAD A CT SCAN LAST MONTH WHICH WAS NORMAL BUT SHOWED BILATERAL INGUINAL HERNIAS CONTAINING BOWEL. HOWEVER IT DID NOT LOOK AS IF THE CAPSULE WAS IN THE GROIN. THE RETENTION WAS DUE TO PATIENT PATHOLOGY NOT EQUIPMENT OR CAPSULE FAILURE. THE PATIENT WAS STILL IN HOSPITAL AT THE TIME OF REPORT.