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

Model Number FGS-0313

Device Problems Signal Artifact/Noise (1036); Poor Quality Image (1408); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 05/07/2019

Event Type  malfunction  

Manufacturer Narrative

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 returned sample did not meet specification as received by medtronic.The customer reported bravo ph high reading.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, when the customer was downloaded the study, they noticed that the study had several blue lines.Technical support logged in to the system and note that it was due to the ignores caused by the capsule.Technical support confirmed that the recorder was operating fine.The customer stated that recorder worked correctly during the previous procedure.There was no patient and user harm and a repeat procedure on a different day was necessary.

• 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: 8755056
• MDR Text Key: 149846252
• Report Number: 9710107-2019-00306
• 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: consumer,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2020
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 44435Q
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2019
• 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: 61 YR
• Patient Weight: 92