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

Model Number	FGS-0636
Medical Device Problem Codes	Positioning Failure (1158); Separation Failure (2547)
Health Effect - Clinical Codes	Oversedation (1990); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the capsule failed to attach.The delivery device was withdrawn, and the capsule fell to the floor as the delivery device left the mouth.Another capsule was attempted to be used and it was unsuccessful.Additional propofol anesthesia time was needed due to the issue.
Additional Manufacturer Narrative
D10 concomitant products: fgs-0636, fgs-0636 cf delivery dev caps bravo x1 (lot#: 67031f).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.
Additional Manufacturer Narrative
Additional information: b5, d1, d4(model number, catalog number, expiration date, lot number and udi), d5, d8, g3, pma/510(k) #, h4, h6.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.
Event or Problem Description
It was reported that the capsule failed to attach.The delivery device was withdrawn, and the capsule fell to the floor as the delivery device left the mouth.Another capsule was attempted to be used and it was unsuccessful as the same issue occurred.The second capsule came out on the delivery device loosely attached.Additional propofol anesthesia time was needed due to the issue.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.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.
Event or Problem Description
It was reported that the capsule failed to attach.The delivery device was withdrawn, and the capsule fell to the floor as the delivery device left the mouth.Another capsule was attempted to be used and it was unsuccessful as the same issue occurred.The second capsule came out on the delivery device loosely attached.Additional propofol anesthesia time was needed due to the issue.There was no patient or user harm.

• 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 55112-4391 ; 8006464633
• MDR Report Key: 24094075
• Report Number: 9710107-2026-00033
• Device Sequence Number: 10243511
• Product Code: FFT
• UDI-Device Identifier: 07290101369714
• UDI-Public: (01)07290101369714(17)270423(10)67031F(20)02
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FGS-0636
• Device Catalogue Number: FGS-0636
• Device Lot Number: 67031F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2025
• Supplement Date Received by Manufacturer: 01/12/2026; 01/23/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 01/21/2026; 01/27/2026
• Date Device Manufactured: 10/23/2025
• 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
• Patient Sex: Unknown