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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 Code Signal Artifact/Noise (1036)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
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, there was a missing traces in the study.Technical support logged into the customer¿s computer and collected the study.There was no patient harm and user harm and no implanted devices.A repeat procedure was necessary due to device malfunction.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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
MDR Report Key9407669
Report Number9710107-2019-00590
Device Sequence Number2966373
Product Code FFT
UDI-Device Identifier07290101363064
UDI-Public07290101363064
Combination Product (Y/N)N
Initial Reporter StateGA
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,Followup
Report Date (Section B) 12/04/2019
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
Initial Date Received by Manufacturer 11/14/2019
Supplement Date Received by Manufacturer11/14/2019
Initial Report FDA Received Date12/04/2019
Supplement Report FDA Received Date12/04/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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