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); Fever (1858); Pain (1994); Perforation of Esophagus (2399); Unintended Radiation Exposure (4565)

Event Date 07/06/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, the capsule was inserted trans-orally after gastroscopy without any problems.No contraindications to construct the ph meter.The nurse felt resistance at the back of the mouth because the tongue was in the way but eventually the capsule went down to the correct position.From there, everything went normal until the physician went to verify correct positioning of the capsule.They took the suction off and pulled the wire up.The capsule was found not fixed to anything in the back of the mouth and lying loosely.It was removed by hand.They used another capsule without any problems and fixed it in the usual way.The control copy showed that it was in place.Superficial lesion was observed where the 1st capsule had been sitting.When the patient woke up, they informed the nurse that the patient had a severe pain at the back of the mouth.Later the same day, the patient was complaining of strong pain in thorax.A ct (computed tomography) scan was performed using per oral contrast.They saw pneumomediastinum caused by esophagus perforation at the same position as the capsule was placed.The patient also experienced pain and fever.The patient was treated with fasting, antibiotics and analgesics.The capsule meter stopped measuring shortly after 2 pm on the day it was placed.After uploading the study again, all data and full investigation were completed.The patient stayed for four days at hospital, now released and doing well.

• 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: 12258632
• MDR Text Key: 264477881
• Report Number: 9710107-2021-00346
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101369707
• UDI-Public: 07290101369707
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2022
• Device Model Number: FGS-0635
• Device Catalogue Number: FGS-0635
• Device Lot Number: 50850F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2021
• Date Device Manufactured: 09/24/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 5 YR