MAUDE Adverse Event Report: COVIDIEN LP BRAVO; ELECTRODE, PH, STOMACH

Model Number FGS-0636

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/10/2021

Event Type  Other  

Event Description

Outpatient at lab for egd with placement of 48 hr ph bravo probe.During procedure bravo probe fell of delivery system in patient mouth and then fell into patient lung.Anesthesia and pulmonary then placed lm airway and performed bronchoscopy to retrieve this device.Egd with bravo study then performed successfully.Patient recovered with no complaints and was discharged to home after procedure with no signs or symptoms.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 16673326
• MDR Text Key: 312630900
• Report Number: 16673326
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/22/2023,08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: FGS-0636
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/22/2023
• Date Report to Manufacturer: 04/04/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1