BRAVO
Received Nov 10, 2017 · Event occurred Mar 24, 2016
Report 9710107-2017-05613 · MDR key 7019600
Device
Generic name
Camera, Still, Surgical
Manufacturer
Given Imaging Ltd., YoqneamModel number
FGS-0312Catalog number
FGS-0312
Lot number
29781Q
Product problems
- High pH
- High pH
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS BASED ON ACCUVIEW GRAPH REVIEW, FOLLOWING REVIEW OF STUDY IT APPEARS THAT THE PH LEVEL IS ABOVE 8PH. DHR (DEVICE HISTORY RECORD): BRAVO CAPSULE, LOT: 29781QQ, PASS. THE CONCLUSION IS HIGH PH READING DUE TO SUSPECTED CAPSULE FAILURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ACCORDING TO THE REPORTER, CUSTOMER CALLED IN TO REPORT THEY HAVE A BRAVO STUDY WHICH THE PH LEVEL WAS VERY HIGH. TECHNICAL SUPPORT WAS ABLE TO TRANSFER STUDY OVER FOR REVIEW AND IT APPEARS THAT THE PH LEVEL ON THIS STUDY STAYED CLOSE TO 9 THROUGHOUT MOST OF THE STUDY. A REPEAT PROCEDURE WAS NECESSARY.