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

Model Number FGS-0636

Device Problem Entrapment of Device (1212)

Patient Problems Chest Pain (1776); Ulcer (2274); Foreign Body In Patient (2687)

Event Date 05/18/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, after completion of 96-hour study, the patient experienced enhance chest pain.After re-scope, the physician found the capsule failed to detached from the esophageal wall after two weeks and caused ulcer at the implantation location.The physician then removed the capsule endoscopically.There was no user harm.

Manufacturer Narrative

Additional information: describe event or problem, date rec¿d by mfr.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, after completion of 96-hour study, the patient experienced enhance chest pain.After re-scope, the physician found the capsule failed to detached from the esophageal wall after two weeks and caused ulcer at the implantation location.The physician then removed the capsule endoscopically using snare and the chest pain has been resolved.The patient received additional anesthesia/ sedation during the removal of the capsule.

• 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: 12073171
• MDR Text Key: 258687246
• Report Number: 9710107-2021-00304
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101369714
• UDI-Public: 07290101369714
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2022
• Device Model Number: FGS-0636
• Device Catalogue Number: FGS-0636
• Device Lot Number: 52090F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2021
• Date Device Manufactured: 01/24/2021
• 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