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

Model Number	FGS-0634
Medical Device Problem Code	Failure to Transmit Record (1521)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: this report is based on information provided by medtronic investigation personnel.The bravo was received for evaluation.The returned sample did not meet specification as received by medtronic.The visual inspection found no notable conditions.The customer reported the recorder failed to upload.The reported condition was confirmed.The investigation found that data in the bravo is corrupted, this was led to the reported problem.The investigation found the most probable cause to be the data failure.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.Technical support remotely accessed the site and confirmed that the recorder "study to upload".Technical support had the customer try multiple ports, rebooted the computer, reset the recorder, but it still gave the message that the upload failed.The data extraction failed as it would not detect the recorder for upload.The recorder worked correctly during the previous procedure.The patient had to undergo another esophagogastroduodenoscopy procedure with capsule placement.There was no patient or user harm.

• Brand Name: BRAVO CF
• Common Device Name: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• MDR Report Key: 8733387
• Report Number: 9710107-2019-00286
• Device Sequence Number: 2572769
• Product Code: FFT
• UDI-Device Identifier: 07290101369691
• UDI-Public: 07290101369691
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2019

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 Model Number: FGS-0634
• Device Catalogue Number: FGS-0634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR