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

Model Number FGS-0636

Device Problem Entrapment of Device (1212)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

This product is not sold in us and is 510(k) exempt.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, a capsule that was placed was still attached in the patient's esophagus.There was no reported patient outcome.

Manufacturer Narrative

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

Event Description

According to the reporter, a capsule, that was placed on october 7th, was still attached in the patient's esophagus.The product was removed endoscopically about 3 weeks after it was deployed.The patient is doing well. .

Manufacturer Narrative

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

Event Description

According to the reporter, a capsule, that was placed and was still attached in the patient's esophagus.The product was removed endoscopically about 3 weeks after it was deployed.

Manufacturer Narrative

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

Event Description

According to the reporter, a capsule, that was placed and was still attached in the patient's esophagus.The product was removed end oscopically about 3 weeks after it was deployed.

• Brand Name: 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: 9298569
• MDR Text Key: 165953050
• Report Number: 9710107-2019-00540
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101369714
• UDI-Public: 07290101369714
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FGS-0636
• Device Catalogue Number: FGS-0636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2019
• 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