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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-0313
Medical Device Problem Code Loss of or Failure to Bond (1068)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/07/2018
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 capsule failed to attach to the patient's esophagus.There was no harm to the patient; no intervention was required.The procedure was repeated.Prior to the procedure, an endoscopy was performed and showed the esophagus to be normal.No lubrication was used to facilitate placement of the capsule.
 
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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 Key9492304
Report Number9710107-2018-00697
Device Sequence Number19578641
Product Code FFT
UDI-Device Identifier07290101361695
UDI-Public07290101361695
Combination Product (Y/N)N
Initial Reporter StateTX
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) 12/18/2019
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 Expiration Date12/20/2018
Device Model NumberFGS-0313
Device Catalogue NumberFGS-0313
Device Lot Number38210Q
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/07/2018
Initial Report FDA Received Date12/19/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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