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

Model Number	FGS-0634
Medical Device Problem Codes	Failure to Transmit Record (1521); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product is not sold in us and is 510(k) exempt.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, when they tried to upload the study on the recorder, it had an error message stating that there might not be any data on it.There was also a message on the recorder stating that the last study data was not yet uploaded.The malfunction was noticed when they were downloading the data.They got a copy of the error.A repeat procedure scheduled on another day with additional anesthesia was necessary.There was no patient and user harm.
Additional Manufacturer Narrative
Evaluation summary: this report is based on information provided by post market vigilance investigation personnel.The product sample was not returned to the medtronic laboratory; however, a data file was provided by the customer for analysis.The customer reported when they tried to upload the study on the recorder, it had an error message stating that there might not be any data on it.The reported condition was confirmed.According to received picture main suspected that the data on the bravo recorder is corrupted for unknown reason.The returned sample did not met specification as received by medtronic.The investigation found the most probable cause to be the data failure.A review of the device history records indicating that the product was released meeting finished product specifications.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, when they tried to upload the study on the recorder, it had an error message stating that there might not be any data on it.There was also a message on the recorder stating that the last study data was not yet uploaded.The malfunction was noticed when they were downloading the data.They got a copy of the error.A repeat procedure scheduled on another day with additional anesthesia was necessary.There was no patient and user harm.

• Brand Name: BRAVO
• Common Device Name: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• MDR Report Key: 9419796
• Report Number: 9710107-2019-00597
• Device Sequence Number: 10935239
• Product Code: FFT
• UDI-Device Identifier: 07290101369691
• UDI-Public: 07290101369691
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 03/29/2020

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-0634
• Device Catalogue Number: FGS-0634
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/31/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 12/10/2019; 12/10/2019
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 12/20/2019; 03/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 126