MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM BRAVO; ELECTRODE, PH, STOMACH

Model Number	FGS-0634
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/23/2019
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, the recorder failed to upload and it was not recognized by the computer.They attempted multiple times, but it still failed.The recorder will be returned for data extraction and the recorder worked correctly during the previous procedure.A repeat procedure was necessary.There was no reported patient outcome.
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 recorder failed to upload and it was not recognized by the computer.They attempted multiple times, but it still failed.The recorder will be returned for data extraction and the recorder worked correctly during the previous procedure.A repeat procedure was necessary.There was no reported patient outcome.

• Brand Name: BRAVO
• Common Device Name: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• MDR Report Key: 9365545
• Report Number: 9710107-2019-00576
• Device Sequence Number: 10935237
• Product Code: FFT
• UDI-Device Identifier: 07290101369691
• UDI-Public: 07290101369691
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K102543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2020

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 Model Number: FGS-0634
• Device Catalogue Number: FGS-0634
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 03/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1