BRAVO FGS-0312

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-11-10 for BRAVO FGS-0312 manufactured by Given Imaging Ltd., Yoqneam.

Event Text Entries

[92643253] 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.
Patient Sequence No: 1, Text Type: N, H10


[92643254] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9710107-2017-05612
MDR Report Key7019523
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2017-11-10
Date of Report2017-11-10
Date of Event2016-03-29
Date Mfgr Received2017-01-29
Date Added to Maude2017-11-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSHARON MURPHY
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone2034925297
Manufacturer G1GIVEN IMAGING LTD., YOQNEAM
Manufacturer StreetYETSIRA 13 STREET
Manufacturer CityYOQNEAM 20692
Manufacturer Postal Code20692
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBRAVO
Generic NameCAMERA, STILL, SURGICAL
Product CodeFTT
Date Received2017-11-10
Returned To Mfg2017-06-23
Model NumberFGS-0312
Catalog NumberFGS-0312
Lot Number29519Q
Device Expiration Date2016-10-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerGIVEN IMAGING LTD., YOQNEAM
Manufacturer AddressYETSIRA 13 STREET YOQNEAM 20692 20692


Patients

Patient NumberTreatmentOutcomeDate
10 2017-11-10

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