InjuryNSI
PILLCAM
Received Apr 17, 2018
Report 9710107-2018-00564 · MDR key 7436861
Device
Generic name
System, Imaging, Esophageal, Wireless, Capsule
Manufacturer
Given Imaging Ltd., YoqneamModel number
FGS-0109Catalog number
FGS-0109
Product problems
- Entrapment of Device
- Entrapment of Device
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
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 CAPSULE HAS NOT DISSOLVED AFTER 48 HOURS OF INGESTION. ACCOUNT MANAGER ADVISED THAT PHYSICIAN PERFORMED X-RAYS AT 24 HOURS AND 48 HOURS AND CAPSULE HAS NOT DISSOLVED. THEY CONFIRMED THAT THE PATIENT WAS ASYMPTOMATIC AND TOLD THE PATIENT THAT IT COULD TAKE LONGER FOR THE CAPSULE TO DISSOLVE. PATIENT IS CURRENTLY STABLE.