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

Model Number FGS-0634

Device Problem Failure to Transmit Record (1521)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2019

Event Type  malfunction  

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 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
• 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 ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 8733387
• MDR Text Key: 149172009
• Report Number: 9710107-2019-00286
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101369691
• UDI-Public: 07290101369691
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/05/2019
• Initial Date FDA Received: 06/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR