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

Model Number FGS-0635

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/08/2022

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 had a retained capsule.There was no reported patient outcome.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IS 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IS 20692
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 13693348
• MDR Text Key: 286762292
• Report Number: 9710107-2022-00048
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101369707
• UDI-Public: 07290101369707
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2023
• Device Model Number: FGS-0635
• Device Catalogue Number: FGS-0635
• Device Lot Number: 54590F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2022
• Date Device Manufactured: 09/29/2021
• 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
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 99 KG