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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
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/05/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, they had an issue pairing a bravo capsule to a recorder.There was a capsule mismatch error with "0000", at the time of the call customer already started the procedure by using the second capsule, new capsule was calibrated with a different recorder then malfunctioning capsule was removed and a new capsule deployed, the recorder was okay to put back in use.The recorder work correctly during the previous procedure, technical support confirmed with the customer that there were no changes made to the recorder after the calibration was completed.In addition, removal of the capsule did cause mild tissue damage to the area, bleeding was noted to the site.The patient had to undergo a longer time of sedation, it was done the same day during same procedure event.The last known patient status was good and there was no treatment provided nor medical intervention done for the mild tissue damage to the patient.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The device was not returned to medtronic for evaluation.Without the device, a root cause of the event could not be determined.The file will be closed as unconfirmed at this time.If additional information is obtained, or the sample is returned, we will re-open this investigation.If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, they had an issue pairing a bravo capsule to a recorder.There was a capsule mismatch error with "0000", at the time of the call customer already started the procedure by using the second capsule, new capsule was calibrated with a different recorder then malfunctioning capsule was removed and a new capsule deployed, the recorder was okay to put back in use.The recorder work correctly during the previous procedure, technical support confirmed with the customer that there were no changes made to the recorder after the calibration was completed.In addition, removal of the capsule did cause mild tissue damage to the area, bleeding was noted to the site.The patient had to undergo a longer time of sedation, it was done the same day during same procedure event.The last known patient status was good and there was no treatment provided nor medical intervention done for the mild tissue damage to the patient.
 
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Brand Name
BRAVO
Type of Device
ELECTRODE, PH, STOMACH
Manufacturer (Section D)
GIVEN IMAGING LTD., YOQNEAM
yetsira 13 street
yoqneam 20692
Manufacturer (Section G)
GIVEN IMAGING LTD., YOQNEAM
yetsira 13 street
yoqneam 20692
Manufacturer Contact
amy beeman
15 hampshire street
mansfield,ma, CO 02048
7632104064
MDR Report Key7374625
MDR Text Key103600125
Report Number9710107-2018-00424
Device Sequence Number1
Product Code FFT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102543
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Nurse
Type of Report Initial,Followup,Followup
Report Date 06/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFGS-0313
Device Catalogue NumberFGS-0313
Device Lot Number37378Q
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/12/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age50 YR
Patient Weight118
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