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

Model Number FGS-0635

Device Problem Positioning Failure (1158)

Patient Problems Airway Obstruction (1699); Hemorrhage/Bleeding (1888); Cough (4457)

Event Date 03/24/2022

Event Type  Injury  

Event Description

According to the reporter, they had a capsule which failed to attach to the patient¿s esophagus.It did attach to the esophagus, but fell off immediately.The patient experienced a little bit of bleeding and coughing while trying to place the bravo capsule.The capsule was retrieved using a snare.Lubrication was used to facilitate the placement of the capsule.

Manufacturer Narrative

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

• 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: 14269833
• MDR Text Key: 290692023
• Report Number: 9710107-2022-00109
• 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: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2023
• Device Model Number: FGS-0635
• Device Catalogue Number: FGS-0635
• Device Lot Number: 55386F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2022
• Date Device Manufactured: 12/23/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 68 KG