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

Model Number FGS-0635

Device Problem Positioning Failure (1158)

Patient Problems Airway Obstruction (1699); Respiratory Insufficiency (4462)

Event Date 10/28/2021

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 three capsules which failed to attach to the patient¿s esophagus.The first two capsules were found in the patient¿s stomach.The third capsule was found in the patient's mouth and was retrieved using a snare.The patient did experience respiratory distress during the procedure, but it was reported that the patient was extremely obese.The physician verified the capsule placement endoscopically.No lubricant was used to facilitate the 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 ; IS 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IS 20692
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 12834057
• MDR Text Key: 280938365
• Report Number: 9710107-2021-00469
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2023
• Device Model Number: FGS-0635
• Device Catalogue Number: FGS-0635
• Device Lot Number: 54188F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2021
• Date Device Manufactured: 08/01/2021
• 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