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

Model Number FGS-0450

Device Problem Failure to Transmit Record (1521)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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.

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 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
• 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: 8928934
• MDR Text Key: 155534208
• Report Number: 9710107-2019-00387
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101363064
• UDI-Public: 07290101363064
• 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: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: FGS-0450
• Device Catalogue Number: FGS-0450
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/05/2019
• Initial Date FDA Received: 08/25/2019
• Supplement Dates Manufacturer Received: 09/02/2019
• Supplement Dates FDA Received: 09/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10 YR