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

Model Number FGS-0635

Device Problem Positioning Failure (1158)

Patient Problems Aspiration/Inhalation (1725); Injury (2348)

Event Date 11/03/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, they had a capsule which failed to attach.It was the found in the pharynx.The patient was under propofol then underwent endotracheal intubation to protect the airway.The scope was re-inserted into the pharynx and the capsule was retrieved with a roth net.There was no harm to the user.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.No lubrication was used to facilitate placement ofthe capsule and the delivery system and capsule will be returned for investigation.Another capsule from a different lot was then deployed.Again, all steps were performed but the capsule failed to attach again.At the third attempt, the capsule did attach but then failed to detach from the delivery device.The delivery device could not be removed.The endoscope was inserted into the esophagus and then the capsule seemed to separate from the deployment device.The capsule was seen to be securely attached to the mucosa in t he correct position.The patient was then extubated and discharged home after a recovery period.The patient was discharged home at about 4pm after the initial procedure was performed at about 11:30am.Typically, if the first procedure had proceeded according to plan uneventfully, the patient would have been discharged home at about 1:15pm.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IL 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IL 20692
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 10837113
• MDR Text Key: 216154681
• Report Number: 9710107-2020-00644
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101369707
• UDI-Public: 07290101369707
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2022
• Device Model Number: FGS-0635
• Device Catalogue Number: FGS-0635
• Device Lot Number: 50371F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2020
• Date Device Manufactured: 07/06/2020
• 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 Outcome(s): Required Intervention