InjuryNSI
PILLCAM
Received Jun 28, 2019 · Event occurred Mar 27, 2019
Report 9710107-2019-00298 · MDR key 8746659
Device
Generic name
System, Imaging, Esophageal, Wireless, Capsule
Manufacturer
Given Imaging Ltd., YoqneamModel number
FGS-0109Catalog number
FGS-0109
Lot number
45103
Product problems
- Entrapment of Device
- Entrapment of Device
Patient
34 YR
- Foreign Body In Patient
- Foreign Body In 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 CAPSULED FAILED TO DISSOLVE AND THE PATIENT EXPERIENCED GASTROINTESTINAL PROBLEMS DUE TO THIS FAILURE, SO AN OPERATION WAS REQUIRED TO REMOVE THE CAPSULE WHICH ALSO REQUIRED AN EXTENDED HOSPITALIZATION OF OVER ONE WEEK. THE CAPSULE WAS INGESTED AND REMOVED. A REPEAT PROCEDURE WAS NOT NECESSARY.