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

Model Number FGS-0634

Device Problems Failure to Transmit Record (1521); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2019

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 trying to start the study, but it kept repeating prompts that the capsule could not be paired.They were unaware that there was a separate catheter that needed to be used if they were going to place the capsule without calibrating it.Technical support had the customer power off the recorder and went back thru the process, but it kept repeating.The recorder worked correctly during the previous procedure.There was no patient and user harm and a repeat procedure was necessary using the correct capsule.

• 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: 8795169
• MDR Text Key: 151190509
• Report Number: 9710107-2019-00337
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/16/2019

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-0634
• Device Catalogue Number: FGS-0634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2019
• Initial Date FDA Received: 07/16/2019
• Date Device Manufactured: 10/18/2018
• 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