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	03/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, they had a capsule which failed to attach and the patient had a tear on the esophageal wall.After firing of the capsule and the delivery system has been removed, the capsule failed to attach on the esophageal wall and so found missing.There was no intervention required, and a repeat procedure was needed.The anesthesia was not able to well control the patient and made the patient fell asleep.Patient was moving during vacuum suction applied and even the firing procedure.An endoscopy had been performed prior to the procedure and showed the esophagus to be normal.A lubricant was used to facilitate placement of the capsule.The patient was prepped for the procedure and was under anesthesia.
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, they had a capsule which failed to attach and the patient had a tear on the esophageal wall.After firing of the capsule and the delivery system has been removed, the capsule failed to attach on the esophageal wall and the capsule went to the patient's stomach.There was no intervention required, and another capsule was used to repeat the procedure on the same day.The patient was not overly sedated, but the anesthesia was unable to control the patient well and the patient got irritated by the procedure.Patient was moving during vacuum suction applied and even the firing procedure.An endoscopy had been performed prior to the procedure and showed the esophagus to be normal.A lubricant was used to facilitate placement of the capsule.The patient was prepped for the procedure and was under anesthesia.

• Brand Name: BRAVO
• Common Device Name: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• MDR Report Key: 8513749
• Report Number: 9710107-2019-00160
• Device Sequence Number: 1651506
• Product Code: FFT
• UDI-Device Identifier: 07290101361695
• UDI-Public: 07290101361695
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K102543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2019

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: 01/15/2020
• Device Model Number: FGS-0312
• Device Catalogue Number: FGS-0312
• Device Lot Number: 44077Q
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR