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

Model Number	FGS-0312
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during procedure, the capsule was delivered endoscopically, but it dislodged on first attempt.A second capsule was calibrated, and the same malfunction occurred with second capsule.Second capsule placement was attempted during the same procedure.After the second capsule failed to attach, they decided to abandon the procedure.The customer had also confirmed that all suction was working correctly and checked as per instructions prior to deployment of the capsule.The capsules were unable to be collected as they were inside the patient and will be excreted at some point but not retained.The patient was prepped for procedure.As patient was under sedation, the procedure was abandoned due to time constraints of calibration versus patient time sedated.There was no patient harm.

• Brand Name: BRAVO
• Common Device Name: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IS 20692
• MDR Report Key: 11250176
• Report Number: 9710107-2021-00060
• Device Sequence Number: 3111227
• Product Code: FFT
• UDI-Device Identifier: 07290101361695
• UDI-Public: 07290101361695
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2021

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-0312
• Device Catalogue Number: FGS-0312
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 01/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1