MalfunctionFFR
BRAVO
Received Nov 7, 2011
Report 9710107-2011-01069 · MDR key 2360959
Device
Generic name
Bravo Ph Capsule
Manufacturer
Given Imaging Ltd.Model number
BRAVO PH CAPSULECatalog number
FGS-0313
Lot number
15787Q
Product problems
- Positioning Failure
Patient
Not reported
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
THIS CASE WAS REPORTED FROM (B)(6). CUSTOMER REPORTED ON A BRAVO PH CAPSULE THAT FAILED TO DETACH FROM DELIVERY SYSTEM. THE PATIENT SUFFERED FROM SLIGHT BLEEDING ON THE ESOPHAGUS. THIS USER PLACED ANOTHER CAPSULE TO THE PATIENT SUCCESSFULLY RIGHT AFTER THE FIRST ONE FAILED. NO FURTHER INFORMATION WAS RECEIVED.