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 Code	Laceration(s) of Esophagus (2398)
Date of Event	11/09/2019
Type of Reportable Event	Serious Injury
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 deploy from the catheter after it was clipped which caused tear in esophagus.The event required intervention.
Additional Manufacturer Narrative
Additional info: ethnicity: white.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 deploy from the catheter after it was clipped which caused tear in esophagus.The event required clips to fix the esophageal tear.A repeat procedure on another day was not necessary.

• Brand Name: BRAVO
• Common Device Name: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• MDR Report Key: 9505965
• Report Number: 9710107-2019-00629
• Device Sequence Number: 2981371
• Product Code: FFT
• UDI-Device Identifier: 07290101361695
• UDI-Public: 07290101361695
• Combination Product (Y/N): N
• PMA/510(K) Number: K102543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2020

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 Expiration Date: 08/11/2020
• Device Model Number: FGS-0312
• Device Catalogue Number: FGS-0312
• Device Lot Number: 46939Q
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 69