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

Model Number	FGS-0450
Medical Device Problem Code	Failure to Transmit Record (1521)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2019
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, they were unable to upload the study because the recorder was not detected.They did a hard reset to the recorder, swapped the usb ports, and the issue persisted.They were able to detect a second recorder.The customer was requesting for a data extraction.The recorder worked correctly during the previous procedure and has been returned for investigation.They attempted to upload the study and the usb port was working on the recorder, but the recorder was not recognized by the computer and would not charge.There was no patient and user harm and a repeat procedure was necessary.
Additional Manufacturer Narrative
Evaluation summary: this report is based on information provided by post market vigilance investigation personnel.The bravo was received for evaluation.The visual inspection found that the usb connector is damaged.The customer reported they were unable to upload the study because the recorder was not detected.The reported condition was confirmed.The investigation found that the usb connector is damaged, main suspected misuse.The investigation found the most probable cause to be the connector user damaged.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, they were unable to upload the study because the recorder was not detected.They did a hard reset to the recorder, swapped the usb ports, and the issue persisted.They were able to detect a second recorder.The recorder worked correctly during the previous procedure and has been returned for investigation.The recorder was disassembled and tested in the laboratory and it broke down while attempting to extract the data from it.They attempted to upload the study and the usb port was working on the recorder, but the recorder was not recognized by the computer and would not charge.After many attempts which included soldering a usb, they were able to download the data via the software version 6.0.A copy of the study was sent in for review.There was no patient and user harm and a repeat procedure was necessary.

• Brand Name: BRAVO
• Common Device Name: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• MDR Report Key: 8928934
• Report Number: 9710107-2019-00387
• Device Sequence Number: 311163
• Product Code: FFT
• UDI-Device Identifier: 07290101363064
• UDI-Public: 07290101363064
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2019

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-0450
• Device Catalogue Number: FGS-0450
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 09/02/2019
• Initial Report FDA Received Date: 08/25/2019
• Supplement Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 10 YR