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

Model Number	FGS-0312
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	03/07/2019
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, the capsule failed to attach on the patient's esophagus.There was no reported patient outcome.
Additional Manufacturer Narrative
Additional information: if information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, there was nothing unusual about the patient or the procedure and an endoscopy had been performed prior to the procedure and showed the esophagus to be normal.However, the capsule failed to attach on the patient¿s esophagus.There was no harm to the patient and the user, no intervention was required, and a repeat procedure was performed, and a new capsule was used.No lubrication was used to facilitate placement of the capsule.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: BRAVO
• Common Device Name: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• MDR Report Key: 8458583
• Report Number: 9710107-2019-00128
• Device Sequence Number: 2887356
• Product Code: FFT
• UDI-Device Identifier: 07290101361695
• UDI-Public: 07290101361695
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K102543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2019

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 Expiration Date: 06/19/2019
• Device Model Number: FGS-0312
• Device Catalogue Number: FGS-0312
• Device Lot Number: 40985Q
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2019
• Supplement Date Received by Manufacturer: 03/30/2019; 05/16/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 04/19/2019; 06/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 65