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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 Problems Misconnection (1399); Device-Device Incompatibility (2919)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 07/09/2018
Event Type  malfunction  
Manufacturer Narrative
Occupation: na (other).If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, they were unable to get the capsule pair with the recorder after a successful calibration.Technical support had the customer power on and off the recorder, but was still unable to pair with the capsule.They confirmed that the recorder had an updated firmware.The capsule and recorder will be returned for investigation.The recorder worked correctly during the previous procedure.The patient was discharged, but will have to be rescheduled and a repeat procedure is necessary.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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
5920 longbow drive
boulder, CO 80301
7632104064
MDR Report Key7727221
MDR Text Key115523577
Report Number9710107-2018-00870
Device Sequence Number1
Product Code FFT
UDI-Device Identifier07290101361688
UDI-Public7290101361688
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 user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/05/2018
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
Device Operator Health Professional
Device Model NumberFGS-0313
Device Catalogue NumberFGS-0313
Device Lot Number40979Q
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/16/2018
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/12/2018
Initial Date FDA Received07/27/2018
Supplement Dates Manufacturer Received08/08/2018
Supplement Dates FDA Received10/05/2018
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 Age59 YR
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