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

Model Number FGS-0313

Device Problem Low pH (4005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product sample was not returned to the medtronic laboratory; however, a study graph was provided by the customer for analysis.The customer reported the study had high ph values.The reported condition was confirmed.The investigation found that according to the graph there was a failure in the ph sensor of the bravo capsule resulting in false high reading of ph.The investigation identified the cause of the reported event to be ph sensor of capsule.Corrective actions have been implemented to mitigate this issue.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the study had high ph values.After the deployment, the capsule was visualized with good attachment at 37cm.As soon as the study was initiated, the ph reading did not read correctly.Rather than a number value that should appear on the ph display, the monitor read "l.I" or "l.1".The customer pushed a few other buttons which seemed to work correctly.The blue/whitelight in the lower right hand corner randomly flashed correctly.Technical support gained remote access and obtained a copy of the study.A repeat procedure scheduled on another day was necessary.There was no patient and user harm.

• 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: 9451154
• MDR Text Key: 170321579
• Report Number: 9710107-2019-00608
• 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
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2020
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 45712Q
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2019
• 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: 66 YR