BRAVO
Received Nov 10, 2017 · Event occurred Apr 20, 2016
Report 9710107-2017-05610 · MDR key 7018907
Device
Generic name
Camera, Still, Surgical
Manufacturer
Given Imaging Ltd., YoqneamModel number
FGS-0312Catalog number
FGS-0312
Lot number
30496Q
Product problems
- Premature Activation
- Premature Activation
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: THE INVESTIGATION IS BASED ON RAPID PH GRAPH REVIEW AND ON THE GRAPH IT APPEARS THAT THE PH LEVEL DROPS BELOW 4 PH AND THEN INCREASES TO 8 PH. DHR (DEVICE HISTORY RECORD): BRAVO CAPSULE, LOT: 30496Q, PASS. SINCE THERE ARE PH LEVEL SURGES ON THE GRAPH, IT CAN BE CONCLUDED THAT THE CAPSULE DETACHED EARLIER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ACCORDING TO THE REPORTER, CUSTOMER CALLED TO REPORT A BRAVO CAPSULE EARLY DETACHMENT. PER TECH, REVIEWED STUDY SUBMITTED VIA EMAIL, TRACINGS INDICATE THE CAPSULE DETACHED SHORTLY AFTER IT WAS PLACED. A REPEAT PROCEDURE WAS NECESSARY.