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

Model Number UNKNOWN BRAVO

Device Problem Entrapment of Device (1212)

Patient Problems Radiation Exposure, Unintended (3164); No Information (3190)

Event Type  Injury  

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.

Manufacturer Narrative

Additional info: (intervention required),(serious injury), (fdp).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, they had a retained capsule.It was confirmed with a chest x-ray that the capsule dislodged from the esophagus approximately 15 days after placement.The patient did not return for another procedure.

• Brand Name: UNK-BRAVO
• 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: 8545071
• MDR Text Key: 142927419
• Report Number: 9710107-2019-00178
• Device Sequence Number: 1
• Product Code: FFT
• 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,Followup
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UNKNOWN BRAVO
• Device Catalogue Number: UNKNOWN BRAVO
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/24/2019
• 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