BRAVO
Received Nov 1, 2017 · Event occurred Oct 24, 2017
Report 9710107-2017-05598 · MDR key 6992751
Device
Generic name
Electrode, Ph, Stomach
Manufacturer
Given Imaging Ltd., YoqneamModel number
FGS-0312Catalog number
FGS-0312
Lot number
34582Q
Product problems
- Failure To Adhere Or Bond
- Failure To Adhere Or Bond
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To 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 CUSTOMER CALLED WITH A BRAVO CAPSULE THAT FAILED TO DETACH FROM THE DELIVERY DEVICE TO THE PATIENTS ESOPHAGUS. FOLLOW-UP HAS BEEN SENT FOR ADDITIONAL INFORMATION.
Additional Manufacturer Narrative
DEVICE EVALUATION: ONE BRAVO PH CAPSULE DELIVERY DEVICE AND ONE CAPSULE WERE RECEIVED FOR INVESTIGATION. THE CAPSULE WAS NOT ATTACHED TO THE DELIVERY DEVICE. VISUAL INSPECTION DID NOT REVEAL ANY DAMAGE, AND APPEARS TO HAVE FUNCTIONED WITHIN SPECIFICATION. FUNCTIONAL TESTING COULD NOT BE PERFORMED BECAUSE THIS IS A SINGLE USE DEVICE AND ONCE THE CAPSULE IS DELIVERED, IT CANNOT BE FUNCTIONALLY TESTED. INVESTIGATION CONCLUSION FOR THE FAILURE TO ATTACH COULD NOT BE RELIABLY DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND INDICATES THAT THE PRODUCT WAS RELEASED MEETING FINISHED PRODUCT SPECIFICATIONS. WE WERE UNABLE TO CONFIRM THE CUSTOMER¿S REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.