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

Model Number FGS-0313

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Information (3190)

Event Date 04/03/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the patient was being treated for gastroesophageal reflux.The patient had esophagogastroduodenoscopy with capsule placement, but the capsule migrated after placement.The patient was then rescheduled for repeat esophagogastroduodenoscopy with capsule placement on the same day.During the repeat procedure esophagogastroduodenoscopy was completed and capsule was deployed.However, it did not attach on the patient¿s esophagus.The patient took a deep breath and appeared to aspirate the capsule and it could not be located on the patient¿s esophagus.A pulmonologist was called, and an emergent bronchoscopy was performed.The airway was clear, a repeat esophagogastroduodenoscopy was performed, and the capsule was found and retrieved.The patient was discharged home on the same day.

• 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: 8638645
• MDR Text Key: 146057023
• Report Number: 9710107-2019-00223
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101361688
• UDI-Public: 07290101361688
• Combination Product (y/n): N
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/23/2019

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
• Device Operator: Health Professional
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/02/2019
• Initial Date FDA Received: 05/23/2019
• 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