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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 Positioning Failure (1158)
Health Effect - Clinical Code Airway Obstruction (1699)
Date of Event 10/13/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Uf/importer rpt num: (b)(4).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 and fell into the esophagus.The capsule was retrieved but the with an unknown device.They calibrated a new capsule and it deployed successfully.The patient was now stable.
 
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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
IS  20692
MDR Report Key12315355
Report Number9710107-2021-00371
Device Sequence Number3165342
Product Code FFT
UDI-Device Identifier07290101361688
UDI-Public07290101361688
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K102543
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date10/01/2021
Device Model NumberFGS-0313
Device Catalogue NumberFGS-0313
Device Lot Number48065Q
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/28/2021
Initial Report FDA Received Date08/12/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age75 YR
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