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

Model Number FGS-0634

Device Problem Data Problem (3196)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: this report is based on information provided by medtronic investigation personnel.The product sample was not returned to the medtronic laboratory; however, a picture was provided by the customer for analysis.The customer reported the uploaded study failed with 48.5 hours of unrecoverable data.The reported condition was confirmed.The investigation found: according to attached files main suspected that the data in the recorder was corrupted, for unknown reason.The investigation found the most probable cause to be the data failure.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the uploaded study filled with 48.5 hours of unrecoverable data.Technical support logged into the customer's computer and took a screen shot of the study.The recorder worked correctly during the previous procedure.There was no patient and user harm and a repeat procedure was necessary.

• Brand Name: BRAVO CF
• 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: 8886555
• MDR Text Key: 154235124
• Report Number: 9710107-2019-00369
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101369691
• UDI-Public: 07290101369691
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FGS-0634
• Device Catalogue Number: FGS-0634
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1