MAUDE Adverse Event Report: GIVEN IMAGING, INC. BRAVO CF CAPSULE; ELECTRODE, PH, STOMACH

Model Number FGS-0636

Device Problems Suction Problem (2170); Misfire (2532); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2022

Event Type  Injury  

Event Description

Bravo ph monitoring device placement unsuccessful for first two attempts (did not deploy, and then suction malfunctioned.) bravo device did not deploy when physician deployed the device.Bravo device then deployed in patient's mouth and physician had to remove device endoscopically."bravo ph monitoring device placed at third attempt successfully.".

• Brand Name: BRAVO CF CAPSULE
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING, INC.
• MDR Report Key: 16148466
• MDR Text Key: 307274729
• Report Number: MW5114285
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/09/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FGS-0636
• Device Catalogue Number: ABF4E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Hispanic