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

Model Number	FGS-0635
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the capsule failed to attach to the patient¿s esophagus and found on the esophagus.Delivery device withdrawn and capsule was retrieve from the esophagus with the device.They placed another capsule on the same procedure and still did not attach.Also retrieve from the esophagus with the device.Third attempt made using capsule from different batch which was instead attempt successful.There was nothing unusual about the patient or the procedure.
Additional Manufacturer Narrative
D10 concomitant product: fgs-0635, fgs-0635 cf delivery dev caps bravo x5, lot(#69612f) medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: Bravo
• Common Device Name: 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(800)646-4633
• MDR Report Key: 50766574
• Report Number: 9710107-2026-00446
• Device Sequence Number: 9195629
• Product Code: FFT
• UDI-Device Identifier: 07290101369707
• UDI-Public: (01)07290101369707(17)271225(10)69612F(20)02
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K102543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FGS-0635
• Device Catalogue Number: FGS-0635
• Device Lot Number: 69612F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 06/25/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown