MalfunctionFTT
BRAVO
Received Nov 10, 2017 · Event occurred Mar 29, 2016
Report 9710107-2017-05612 · MDR key 7019523
Device
Generic name
Camera, Still, Surgical
Manufacturer
Given Imaging Ltd., YoqneamModel number
FGS-0312Catalog number
FGS-0312
Lot number
29519Q
Product problems
- Low Readings
- Low Readings
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION BASED ON ACCVIEW GRAPH, TOTAL TIME OF THE PROCEDURE IS 48 HOURS, THE PH VALUE AT BELOW 4 PH, AND THERE IS IGNORES IN THE PROCEDURE. NO INDICATED TO CAPSULE DETACHED EARLIER.
Description of Event or Problem
ACCORDING TO THE REPORTER, CUSTOMER CALLED TO REPORT A POSSIBLE BRAVO CAPSULE DETACHED EARLY STUDY. UPON REVIEW OF THE STUDY THE FAILURE SYMPTOM WAS DETERMINED TO BE DUE TO BRAVO LOW PH READING. A REPEAT PROCEDURE WAS NECESSARY DUE TO THE MALFUNCTION.