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

Model Number	RFB-0450
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the product sample was not returned to the medtronic laboratory, however, a study graph was provided and investigated.The investigation concluded that there was a failure in the ph sensor of the bravo capsule resulting in a false high reading of ph.The investigation identified the root cause of the reported event to be ph sensor of capsule due to the reference gel drying out in the soaker bulb.This issue has been addressed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, they had a study with lots of blue lines in it which were not able to be erased.Technical support walked the customer through the steps to de-identify the study and sent in for review.Upon receipt of the study, it showed high ph values throughout.There was no patient and user harm and a repeat procedure will need to be completed with anesthesia.
Additional Manufacturer Narrative
Corrected information: if information is provided in the future, a supplemental report will be issued.

• Brand Name: BRAVO
• Common Device Name: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam IL 20692
• MDR Report Key: 7717687
• Report Number: 9710107-2018-00855
• Device Sequence Number: 19081576
• Product Code: FFT
• UDI-Device Identifier: 07290101365303
• UDI-Public: 7290101365303
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2018

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: RFB-0450
• Device Catalogue Number: RFB-0450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 64