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

Model Number FGS-0313

Device Problems Signal Artifact/Noise (1036); Detachment of Device or Device Component (2907); Unintended Application Program Shut Down (4032)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2019

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 a short study.Technical support logged into the customer's computer and confirmed that instead of 48 hours, the study was only 23:50 hours and there were also a number of "ignores" in the study because the capsule fell off.The recorder worked correctly during the previous procedure.There was no patient and user harm and a repeat procedure was necessary.

Manufacturer Narrative

Evaluation summary: this report is based on information provided by medtronic investigation personnel.The product sample was not returned to the medtronic laboratory; however, a study graph was provided by the customer for analysis.The customer reported they had a short study.The reported condition was confirmed.The investigation found that the reported condition was due to bravo system communication failure.The investigation isolated the failure to the bravo communication system, but a cause was not identified.If information is provided in the future, a supplemental report will be issued.

• 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 ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 8733304
• MDR Text Key: 149159723
• Report Number: 9710107-2019-00282
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101361688
• UDI-Public: 07290101361688
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2020
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 44431Q
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2019
• 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: 45 YR
• Patient Weight: 64