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

Model Number FGS-0313

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Sore Throat (2396)

Event Date 10/11/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, they had a failed attempt to place the capsule on a patient.The physician deployed the capsule after following all the steps per protocol.The capsule was calibrated, suction and needle checked by a very experienced nurse.After the capsule was deployed the physician pulled the capsule back and it was still on the delivery system.They attempted to push the catheter back down when the capsule fell off of the catheter and attempted to retrieve but was unable.The capsule was then pushed into the stomach to allow to pass.Another capsule was placed to continue the procedure on the same day.The patient had sore throat following the procedure with no intervention needed.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.Lubrication was used to facilitate placement of the capsule.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 9286600
• MDR Text Key: 165298469
• Report Number: 9710107-2019-00531
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101361688
• UDI-Public: 07290101361688
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/04/2020
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 46546Q
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2019
• Date Device Manufactured: 07/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 86