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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM BRAVO; ELECTRODE, PH, STOMACH
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GIVEN IMAGING LTD., YOQNEAM BRAVO; ELECTRODE, PH, STOMACH Back to Search Results
Model Number FGS-0450
Medical Device Problem Codes Loss of Data (2903); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 01/07/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, the recorder showed an error message of "eeface" when they tried to upload a study.Technical support informed the customer it was indicated there was no data saved to the recorder to upload.Technical support had the customer select start study and the recorder started looking for a capsule indicating that the recorder was ready for a study.A repeat procedure will be performed.There was no patient involvement.
 
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Brand Name
BRAVO
Common Device Name
ELECTRODE, PH, STOMACH
Manufacturer (Section D)
GIVEN IMAGING LTD., YOQNEAM
yetsira 13 street
yoqneam 20692
IL  20692
MDR Report Key9607057
Report Number9710107-2020-00026
Device Sequence Number14120530
Product Code FFT
UDI-Device Identifier07290101363064
UDI-Public07290101363064
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K102543
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberFGS-0450
Device Catalogue NumberFGS-0450
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/07/2020
Initial Report FDA Received Date01/20/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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