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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-0312
Medical Device Problem Code Failure to Transmit Record (1521)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/08/2019
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, they had a capsule which failed to attach.Another capsule was opened, but the customer was unable to cancel the first study that was started on the recorder.A repeat procedure was scheduled on a different day.The customer stated that recorder worked correctly during the previous procedure.There was no patient injury.
 
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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 Key8637923
Report Number9710107-2019-00222
Device Sequence Number11280995
Product Code FFT
UDI-Device Identifier07290101361695
UDI-Public07290101361695
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 health professional,user faci
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/23/2019
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 Date12/31/2019
Device Model NumberFGS-0312
Device Catalogue NumberFGS-0312
Device Lot Number44059Q
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/06/2019
Initial Report FDA Received Date05/23/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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