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

Model Number	FGS-0656
Medical Device Problem Code	High pH (2426)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the study had multiple exclusions due to high ph.A repeat procedure was necessary.The recorder and work station software worked correctly during the previous procedure.There was no patient and user harm.
Additional Manufacturer Narrative
Additional information: if information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the study had multiple exclusions due to high ph.A repeat procedure was performed on a different day.The recorder and work station software worked correctly during the previous procedure.There was no patient and user harm.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: REFLUX
• Common Device Name: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• MDR Report Key: 8586493
• Report Number: 9710107-2019-00204
• Device Sequence Number: 16274788
• Product Code: FFT
• UDI-Device Identifier: 07290110360429
• UDI-Public: 07290110360429
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K102543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2020

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: FGS-0656
• Device Catalogue Number: FGS-0656
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 04/24/2019; 04/24/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 05/17/2019; 03/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 117